{"id":19528,"date":"2023-10-19T12:22:24","date_gmt":"2023-10-19T10:22:24","guid":{"rendered":"https:\/\/biomex.de\/?page_id=19528"},"modified":"2025-10-21T14:26:49","modified_gmt":"2025-10-21T12:26:49","slug":"faq-diagnostik","status":"publish","type":"page","link":"https:\/\/biomex.de\/de\/diagnostik\/faq-diagnostik\/","title":{"rendered":"FAQ Diagnostik"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"19528\" class=\"elementor elementor-19528 elementor-14018\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-71a360a elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"71a360a\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-1fa14f4\" data-id=\"1fa14f4\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4226325 elementor-widget elementor-widget-template\" data-id=\"4226325\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"template.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-template\">\n\t\t\t\t\t<div data-elementor-type=\"section\" data-elementor-id=\"3736\" class=\"elementor elementor-3736\" data-elementor-post-type=\"elementor_library\">\n\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-16dfb095 elementor-section-height-min-height elementor-section-items-bottom elementor-section-full_width elementor-section-height-default\" data-id=\"16dfb095\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-168bd6d2\" data-id=\"168bd6d2\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-6c78d237 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"6c78d237\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-55a6dd30\" data-id=\"55a6dd30\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-17529196\" data-id=\"17529196\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-b6019c4 elementor-absolute elementor-hidden-tablet_extra elementor-hidden-tablet elementor-hidden-mobile_extra elementor-hidden-mobile elementor-view-default elementor-invisible elementor-widget elementor-widget-icon\" data-id=\"b6019c4\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_position&quot;:&quot;absolute&quot;,&quot;motion_fx_motion_fx_scrolling&quot;:&quot;yes&quot;,&quot;motion_fx_translateY_effect&quot;:&quot;yes&quot;,&quot;motion_fx_translateY_speed&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:3,&quot;sizes&quot;:[]},&quot;_animation&quot;:&quot;slideInDown&quot;,&quot;motion_fx_translateY_affectedRange&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:{&quot;start&quot;:0,&quot;end&quot;:100}},&quot;motion_fx_devices&quot;:[&quot;desktop&quot;,&quot;laptop&quot;,&quot;tablet_extra&quot;,&quot;tablet&quot;,&quot;mobile_extra&quot;,&quot;mobile&quot;]}\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<i aria-hidden=\"true\" class=\"icon icon-signet-right\"><\/i>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ec62c3f elementor-absolute elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-mobile_extra elementor-hidden-mobile elementor-view-default elementor-invisible elementor-widget elementor-widget-icon\" data-id=\"ec62c3f\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_position&quot;:&quot;absolute&quot;,&quot;motion_fx_motion_fx_scrolling&quot;:&quot;yes&quot;,&quot;motion_fx_translateY_effect&quot;:&quot;yes&quot;,&quot;motion_fx_translateY_speed&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:3,&quot;sizes&quot;:[]},&quot;_animation&quot;:&quot;slideInDown&quot;,&quot;motion_fx_translateY_affectedRange&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:{&quot;start&quot;:0,&quot;end&quot;:100}},&quot;motion_fx_devices&quot;:[&quot;desktop&quot;,&quot;laptop&quot;,&quot;tablet_extra&quot;,&quot;tablet&quot;,&quot;mobile_extra&quot;,&quot;mobile&quot;]}\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<i aria-hidden=\"true\" class=\"icon icon-signet-right\"><\/i>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ba0de5b elementor-absolute elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet_extra elementor-hidden-tablet elementor-view-default elementor-invisible elementor-widget elementor-widget-icon\" data-id=\"ba0de5b\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_position&quot;:&quot;absolute&quot;,&quot;motion_fx_motion_fx_scrolling&quot;:&quot;yes&quot;,&quot;motion_fx_translateY_effect&quot;:&quot;yes&quot;,&quot;motion_fx_translateY_speed&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:3,&quot;sizes&quot;:[]},&quot;_animation&quot;:&quot;slideInDown&quot;,&quot;motion_fx_translateY_affectedRange&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:{&quot;start&quot;:0,&quot;end&quot;:100}},&quot;motion_fx_devices&quot;:[&quot;desktop&quot;,&quot;laptop&quot;,&quot;tablet_extra&quot;,&quot;tablet&quot;,&quot;mobile_extra&quot;,&quot;mobile&quot;]}\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<i aria-hidden=\"true\" class=\"icon icon-signet-right\"><\/i>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-96673e5 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"96673e5\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-fa60974\" data-id=\"fa60974\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2e769f6 elementor-widget elementor-widget-shortcode\" data-id=\"2e769f6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-shortcode\">\t\t<div data-elementor-type=\"section\" data-elementor-id=\"16140\" class=\"elementor elementor-16140 elementor-1114 elementor-1114\" data-elementor-post-type=\"elementor_library\">\n\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-60cebac9 elementor-section-full_width elementor-section-height-min-height elementor-section-height-default elementor-section-items-middle\" data-id=\"60cebac9\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-36426147\" data-id=\"36426147\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-16722c7e elementor-align-left elementor-widget elementor-widget-breadcrumbs\" data-id=\"16722c7e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"breadcrumbs.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"breadcrumbs\"><span><span><a href=\"https:\/\/biomex.de\/de\/\">Home<\/a><\/span><\/span><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-d1d2566 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"d1d2566\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-677a597\" data-id=\"677a597\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-cdc1973 elementor-widget elementor-widget-spacer\" data-id=\"cdc1973\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2c00b0b elementor-widget elementor-widget-heading\" data-id=\"2c00b0b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">H\u00e4ufig gestellte Fragen: <br>\nBIOMEX Performance Evaluation Studies<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-4a848ce elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4a848ce\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-bc68f93\" data-id=\"bc68f93\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-ecbd6cd\" data-id=\"ecbd6cd\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-eccabf0 elementor-widget elementor-widget-text-editor\" data-id=\"eccabf0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Wir sind Ihre Experten f\u00fcr Performance Evaluation Studies im Bereich der In-vitro-Diagnostik und der Assay-Validierung. Nachfolgend finden Sie Antworten auf h\u00e4ufig gestellte Fragen zu diesen Themen. F\u00fcr weitere Anliegen z\u00f6gern Sie bitte nicht, uns direkt zu <a href=\"mailto:sales@biomex.de\"><span style=\"text-decoration: underline;\"><span style=\"color: #0000ff; text-decoration: underline;\"><strong>kontaktieren<\/strong><\/span><\/span><\/a>.\u00a0<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<div class=\"elementor-element elementor-element-67ba0f0 elementor-widget elementor-widget-spacer\" data-id=\"67ba0f0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-e5fb53f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"e5fb53f\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-5cf9d75\" data-id=\"5cf9d75\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e575f46 elementor-widget elementor-widget-eael-adv-accordion\" data-id=\"e575f46\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"eael-adv-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t            <div class=\"eael-adv-accordion\" id=\"eael-adv-accordion-e575f46\" data-scroll-on-click=\"no\" data-scroll-speed=\"300\" data-accordion-id=\"e575f46\" data-accordion-type=\"accordion\" data-toogle-speed=\"300\">\n            <div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"1-hintergrund-und-expertise\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"1\" aria-controls=\"elementor-tab-content-2401\"><span class=\"eael-advanced-accordion-icon-closed\"><i aria-hidden=\"true\" class=\"fa-accordion-icon fas fa-plus\"><\/i><\/span><span class=\"eael-advanced-accordion-icon-opened\"><i aria-hidden=\"true\" class=\"fa-accordion-icon fas fa-minus\"><\/i><\/span><h2 class=\"eael-accordion-tab-title\">1. Hintergrund und Expertise<\/h2><i aria-hidden=\"true\" class=\"fa-toggle icon icon-signet-right-colored\"><\/i><\/div><div id=\"elementor-tab-content-2401\" class=\"eael-accordion-content clearfix\" data-tab=\"1\" aria-labelledby=\"1-hintergrund-und-expertise\"><style>.elementor-19529 .elementor-element.elementor-element-6ab94b14{transition:background 0.3s, border 0.3s, border-radius 0.3s, box-shadow 0.3s;padding:5% 0% 5% 0%;}.elementor-19529 .elementor-element.elementor-element-6ab94b14 > .elementor-background-overlay{transition:background 0.3s, border-radius 0.3s, opacity 0.3s;}.elementor-19529 .elementor-element.elementor-element-200cab2f{margin-top:-22px;margin-bottom:0px;}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion, .elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-accordion_media-wrapper{border-style:none;}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .eael-accordion-tab-title, \n                .elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-accordion_media-wrapper .eael-accordion_media-list .eael-accordion_media-content .eael-accordion_media-title{font-family:\"Montserrat\", Sans-serif;font-size:21px;font-weight:700;line-height:1.2em;}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .fa-accordion-icon{font-size:7px;color:#333;}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-header svg.fa-accordion-icon{height:7px;width:7px;line-height:7px;}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-accordion_media-list .eael-accordion_media-icon i{font-size:7px;}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-accordion_media-list .eael-accordion_media-icon svg{height:7px;width:7px;line-height:7px;}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .fa-accordion-icon,\n                    .elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-accordion_media-wrapper .eael-accordion_media-lists .eael-accordion_media-list{gap:10px;}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-header, \n                .elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-accordion_media-wrapper .eael-accordion_media-list{background-color:#02010100;}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .eael-accordion-tab-title{color:var( --e-global-color-text );}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-accordion_media-content .eael-accordion_media-title{color:var( --e-global-color-text );}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .fa-accordion-icon-svg svg{color:#333;fill:#333;}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-header svg{fill:#333;}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-accordion_media-list .eael-accordion_media-icon{color:#333;}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-header,\n                .elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-accordion_media-wrapper .eael-accordion_media-lists .eael-accordion_media-list{border-style:solid;border-width:0px 0px 1px 0px;border-color:var( --e-global-color-primary );}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-header:hover .eael-accordion-tab-title,\n                    .elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-accordion_media-list:not(.active):hover .eael-accordion_media-title{color:var( --e-global-color-primary );}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-header:hover .fa-accordion-icon{color:var( --e-global-color-primary );}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-header:hover .fa-accordion-icon svg{color:var( --e-global-color-primary );fill:var( --e-global-color-primary );}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-header:hover svg.fa-accordion-icon{fill:var( --e-global-color-primary );}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-accordion_media-list:hover .eael-accordion_media-icon i{color:var( --e-global-color-primary );}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-accordion_media-list:hover .eael-accordion_media-icon svg{fill:var( --e-global-color-primary );}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active, \n                .elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-accordion_media-wrapper .eael-accordion_media-list.active{background-color:#FFFFFF00;}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active{color:var( --e-global-color-primary );}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active .eael-accordion-tab-title{color:var( --e-global-color-primary );}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active .fa-accordion-icon{color:var( --e-global-color-primary );}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active .fa-accordion-icon svg{color:var( --e-global-color-primary );fill:var( --e-global-color-primary );}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active svg.fa-accordion-icon{fill:var( --e-global-color-primary );}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-accordion_media-list.active .eael-accordion_media-icon i{color:var( --e-global-color-primary );}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-accordion_media-list.active .eael-accordion_media-icon svg{fill:var( --e-global-color-primary );}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-content{color:#333;}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-accordion_media-list .eael-accordion_media-content .eael-accordion_media-description{color:#333;}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-content,\n                .elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-accordion_media-list .eael-accordion_media-content .eael-accordion_media-description{font-family:var( --e-global-typography-text-font-family ), Sans-serif;font-size:var( --e-global-typography-text-font-size );font-weight:var( --e-global-typography-text-font-weight );line-height:var( --e-global-typography-text-line-height );letter-spacing:var( --e-global-typography-text-letter-spacing );border-style:none;}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .fa-toggle, .elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-header > .fa-toggle-svg{font-size:26px;}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-header svg.fa-toggle{height:26px;width:26px;line-height:26px;fill:#444;}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .fa-toggle{color:#444;}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .fa-toggle svg{color:#444;fill:#444;}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list:hover .eael-accordion-header .fa-toggle{color:var( --e-global-color-63a7be9 );}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list:hover .eael-accordion-header .fa-toggle svg{color:var( --e-global-color-63a7be9 );fill:var( --e-global-color-63a7be9 );}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list:hover .eael-accordion-header svg.fa-toggle{fill:var( --e-global-color-63a7be9 );}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active .fa-toggle{color:var( --e-global-color-63a7be9 );}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active .fa-toggle svg{color:var( --e-global-color-63a7be9 );fill:var( --e-global-color-63a7be9 );}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active svg.fa-toggle{fill:var( --e-global-color-63a7be9 );}@media(max-width:1300px){.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-content,\n                .elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-accordion_media-list .eael-accordion_media-content .eael-accordion_media-description{font-size:var( --e-global-typography-text-font-size );line-height:var( --e-global-typography-text-line-height );letter-spacing:var( --e-global-typography-text-letter-spacing );}}@media(max-width:1024px){.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-content,\n                .elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-accordion_media-list .eael-accordion_media-content .eael-accordion_media-description{font-size:var( --e-global-typography-text-font-size );line-height:var( --e-global-typography-text-line-height );letter-spacing:var( --e-global-typography-text-letter-spacing );}}@media(max-width:767px){.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .eael-accordion-tab-title, \n                .elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-accordion_media-wrapper .eael-accordion_media-list .eael-accordion_media-content .eael-accordion_media-title{font-size:20px;}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-content,\n                .elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-accordion_media-list .eael-accordion_media-content .eael-accordion_media-description{font-size:var( --e-global-typography-text-font-size );line-height:var( --e-global-typography-text-line-height );letter-spacing:var( --e-global-typography-text-letter-spacing );}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .fa-toggle, .elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-header > .fa-toggle-svg{font-size:0px;}.elementor-19529 .elementor-element.elementor-element-5b58c8b6 .eael-adv-accordion .eael-accordion-list .eael-accordion-header svg.fa-toggle{height:0px;width:0px;line-height:0px;}}\/* Start Custom Fonts CSS *\/@font-face {\n\tfont-family: 'Montserrat';\n\tfont-style: normal;\n\tfont-weight: normal;\n\tfont-display: auto;\n\tsrc: url('https:\/\/biomex.de\/wp-content\/uploads\/2022\/11\/montserrat-v25-latin-regular.eot');\n\tsrc: url('https:\/\/biomex.de\/wp-content\/uploads\/2022\/11\/montserrat-v25-latin-regular.eot?#iefix') format('embedded-opentype'),\n\t\turl('https:\/\/biomex.de\/wp-content\/uploads\/2022\/11\/montserrat-v25-latin-regular.woff2') format('woff2'),\n\t\turl('https:\/\/biomex.de\/wp-content\/uploads\/2022\/11\/montserrat-v25-latin-regular.woff') format('woff'),\n\t\turl('https:\/\/biomex.de\/wp-content\/uploads\/2022\/11\/montserrat-v25-latin-regular.ttf') format('truetype'),\n\t\turl('https:\/\/biomex.de\/wp-content\/uploads\/2022\/11\/montserrat-v25-latin-regular.svg#Montserrat') format('svg');\n}\n@font-face {\n\tfont-family: 'Montserrat';\n\tfont-style: normal;\n\tfont-weight: 700;\n\tfont-display: auto;\n\tsrc: url('https:\/\/biomex.de\/wp-content\/uploads\/2022\/11\/montserrat-v25-latin-700.eot');\n\tsrc: url('https:\/\/biomex.de\/wp-content\/uploads\/2022\/11\/montserrat-v25-latin-700.eot?#iefix') format('embedded-opentype'),\n\t\turl('https:\/\/biomex.de\/wp-content\/uploads\/2022\/11\/montserrat-v25-latin-700.woff2') format('woff2'),\n\t\turl('https:\/\/biomex.de\/wp-content\/uploads\/2022\/11\/montserrat-v25-latin-700.woff') format('woff'),\n\t\turl('https:\/\/biomex.de\/wp-content\/uploads\/2022\/11\/montserrat-v25-latin-700.ttf') format('truetype'),\n\t\turl('https:\/\/biomex.de\/wp-content\/uploads\/2022\/11\/montserrat-v25-latin-700.svg#Montserrat') format('svg');\n}\n@font-face {\n\tfont-family: 'Montserrat';\n\tfont-style: italic;\n\tfont-weight: normal;\n\tfont-display: auto;\n\tsrc: url('https:\/\/biomex.de\/wp-content\/uploads\/2022\/11\/montserrat-v25-latin-700italic.eot');\n\tsrc: url('https:\/\/biomex.de\/wp-content\/uploads\/2022\/11\/montserrat-v25-latin-700italic.eot?#iefix') format('embedded-opentype'),\n\t\turl('https:\/\/biomex.de\/wp-content\/uploads\/2022\/11\/montserrat-v25-latin-italic.woff2') format('woff2'),\n\t\turl('https:\/\/biomex.de\/wp-content\/uploads\/2022\/11\/montserrat-v25-latin-italic.woff') format('woff'),\n\t\turl('https:\/\/biomex.de\/wp-content\/uploads\/2022\/11\/montserrat-v25-latin-italic.ttf') format('truetype'),\n\t\turl('https:\/\/biomex.de\/wp-content\/uploads\/2022\/11\/montserrat-v25-latin-italic.svg#Montserrat') format('svg');\n}\n@font-face {\n\tfont-family: 'Montserrat';\n\tfont-style: italic;\n\tfont-weight: 700;\n\tfont-display: auto;\n\tsrc: url('https:\/\/biomex.de\/wp-content\/uploads\/2022\/11\/montserrat-v25-latin-italic.eot');\n\tsrc: url('https:\/\/biomex.de\/wp-content\/uploads\/2022\/11\/montserrat-v25-latin-italic.eot?#iefix') format('embedded-opentype'),\n\t\turl('https:\/\/biomex.de\/wp-content\/uploads\/2022\/11\/montserrat-v25-latin-700italic.woff2') format('woff2'),\n\t\turl('https:\/\/biomex.de\/wp-content\/uploads\/2022\/11\/montserrat-v25-latin-700italic.woff') format('woff'),\n\t\turl('https:\/\/biomex.de\/wp-content\/uploads\/2022\/11\/montserrat-v25-latin-700italic.ttf') format('truetype'),\n\t\turl('https:\/\/biomex.de\/wp-content\/uploads\/2022\/11\/montserrat-v25-latin-italic.svg#Montserrat') format('svg');\n}\n\/* End Custom Fonts CSS *\/<\/style>\t\t<div data-elementor-type=\"section\" data-elementor-id=\"19529\" class=\"elementor elementor-19529 elementor-14027 elementor-14027\" data-elementor-post-type=\"elementor_library\">\n\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-6ab94b14 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6ab94b14\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4aa0b712\" data-id=\"4aa0b712\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-200cab2f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"200cab2f\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-5a37ceda\" data-id=\"5a37ceda\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5b58c8b6 elementor-widget elementor-widget-eael-adv-accordion\" data-id=\"5b58c8b6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"eael-adv-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t            <div class=\"eael-adv-accordion\" id=\"eael-adv-accordion-5b58c8b6\" data-scroll-on-click=\"no\" data-scroll-speed=\"300\" data-accordion-id=\"5b58c8b6\" data-accordion-type=\"accordion\" data-toogle-speed=\"300\">\n            <div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"bae1\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"1\" aria-controls=\"elementor-tab-content-1531\"><span class=\"eael-accordion-tab-title\">1.\tWo in Europa hat BIOMEX seinen Sitz?<\/span><i aria-hidden=\"true\" class=\"fa-toggle icon icon-signet-right-colored\"><\/i><\/div><div id=\"elementor-tab-content-1531\" class=\"eael-accordion-content clearfix\" data-tab=\"1\" aria-labelledby=\"bae1\"><p>Unsere Hauptstandorte befinden sich in Heidelberg, Deutschland, einem der f\u00fchrenden biologischen Forschungszentren Europas. Heidelberg liegt nur eine Stunde mit dem Auto oder der Bahn vom gr\u00f6\u00dften deutschen Flughafen in Frankfurt am Main entfernt.<\/p><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"bae6\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"2\" aria-controls=\"elementor-tab-content-1532\"><span class=\"eael-accordion-tab-title\">2.\tWas zeichnet BIOMEX als CRO f\u00fcr diagnostische Produkte aus?<\/span><i aria-hidden=\"true\" class=\"fa-toggle icon icon-signet-right-colored\"><\/i><\/div><div id=\"elementor-tab-content-1532\" class=\"eael-accordion-content clearfix\" data-tab=\"2\" aria-labelledby=\"bae6\"><p>Einige unserer Alleinstellungsmerkmale, die uns von anderen CROs abheben und uns die Durchf\u00fchrung Ihrer Performance Evaluation Studies mit maximaler Flexibilit\u00e4t und Qualit\u00e4t erm\u00f6glichen, sind:<\/p><ul><li>Probengewinnung in unseren eigenen Spendezentren \u2013 prospektiv und exakt auf Ihre spezifischen Anforderungen abgestimmt<\/li><li>Europas gr\u00f6\u00dftes kommerzielles Bioprobeninventar<\/li><li>100 % der Wertsch\u00f6pfungskette im eigenen Haus, einschlie\u00dflich:<ul><li>Fachkundige regulatorische Unterst\u00fctzung<\/li><li>Studienplanung<\/li><li>Ethikgenehmigungen<\/li><li>Tests in unseren eigenen Laboren<\/li><li>Materialhandling<\/li><li>Management externer Standorte<\/li><\/ul><\/li><\/ul><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"bae2\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"3\" aria-controls=\"elementor-tab-content-1533\"><span class=\"eael-accordion-tab-title\">3.\tWarum gilt BIOMEX als Experte f\u00fcr Performance Evaluation Studies?<\/span><i aria-hidden=\"true\" class=\"fa-toggle icon icon-signet-right-colored\"><\/i><\/div><div id=\"elementor-tab-content-1533\" class=\"eael-accordion-content clearfix\" data-tab=\"3\" aria-labelledby=\"bae2\"><p>Seit 2017 f\u00fchren wir Performance Evaluation Studies f\u00fcr In-vitro-Diagnostika durch. Seither haben wir zahlreiche Hersteller bei der Durchf\u00fchrung von Hunderten solcher Studien unterst\u00fctzt.<\/p><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"bae3\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"4\" aria-controls=\"elementor-tab-content-1534\"><span class=\"eael-accordion-tab-title\">4.\tWoher bezieht BIOMEX die Proben f\u00fcr die Studien?<\/span><i aria-hidden=\"true\" class=\"fa-toggle icon icon-signet-right-colored\"><\/i><\/div><div id=\"elementor-tab-content-1534\" class=\"eael-accordion-content clearfix\" data-tab=\"4\" aria-labelledby=\"bae3\"><p>90 % der Proben stammen aus unseren eigenen Spendezentren in Heidelberg, M\u00fcnchen und Kamerun (Afrika). Unser Inventar umfasst \u00fcber 600.000 Bioproben: Plasma, Serum, Abstriche und Gewebe. Weitere Informationen finden Sie in unserem <a href=\"https:\/\/sampleshop.biomex.de\/\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline\"><strong>Sampleshop.<\/strong><\/span><\/a> Zus\u00e4tzlich beziehen wir regelm\u00e4\u00dfig Restproben \u00fcber unser weltweites Netzwerk und f\u00fchren bei Bedarf prospektive Probenkollektionen f\u00fcr Sie durch.<\/p><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"bae4\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"5\" aria-controls=\"elementor-tab-content-1535\"><span class=\"eael-accordion-tab-title\">5.\tWelche Pr\u00fcflabore betreibt BIOMEX?<\/span><i aria-hidden=\"true\" class=\"fa-toggle icon icon-signet-right-colored\"><\/i><\/div><div id=\"elementor-tab-content-1535\" class=\"eael-accordion-content clearfix\" data-tab=\"5\" aria-labelledby=\"bae4\"><p>Wir betreiben Laboratorien, die Arbeiten mit Proben der Biosicherheitsstufe 3 erm\u00f6glichen. Dazu geh\u00f6ren beispielsweise Proben von HIV, HCV oder SARS-CoV-2.<\/p><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"bae5\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"6\" aria-controls=\"elementor-tab-content-1536\"><span class=\"eael-accordion-tab-title\">6.\tMit welchen speziellen Laborinstrumenten arbeitet BIOMEX?<\/span><i aria-hidden=\"true\" class=\"fa-toggle icon icon-signet-right-colored\"><\/i><\/div><div id=\"elementor-tab-content-1536\" class=\"eael-accordion-content clearfix\" data-tab=\"6\" aria-labelledby=\"bae5\"><p>Neben Standardlaborverfahren bieten wir eine Vielzahl von Tests an, darunter PCR, Klinische Chemie, CLIA\/CMIA, POCT und weitere. Unser Equipment umfasst:<\/p>\n<table id=\"tablepress-28\" class=\"tablepress tablepress-id-28\">\n<thead>\n<tr class=\"row-1\">\n\t<th class=\"column-1\">Company<\/th><th class=\"column-2\">Instrument<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-striping row-hover\">\n<tr class=\"row-2\">\n\t<td class=\"column-1\">Roche<\/td><td class=\"column-2\">Cobas e411<\/td>\n<\/tr>\n<tr class=\"row-3\">\n\t<td class=\"column-1\">Roche<\/td><td class=\"column-2\">Cobas c501<\/td>\n<\/tr>\n<tr class=\"row-4\">\n\t<td class=\"column-1\">Roche<\/td><td class=\"column-2\">Cobas 5800<\/td>\n<\/tr>\n<tr class=\"row-5\">\n\t<td class=\"column-1\">Abbott<\/td><td class=\"column-2\">Architect i1000SR<\/td>\n<\/tr>\n<tr class=\"row-6\">\n\t<td class=\"column-1\">Diasorin<\/td><td class=\"column-2\">Liason XL<\/td>\n<\/tr>\n<tr class=\"row-7\">\n\t<td class=\"column-1\">BioM\u00e9rieux<\/td><td class=\"column-2\">MiniVidas<\/td>\n<\/tr>\n<tr class=\"row-8\">\n\t<td class=\"column-1\">ThermoScientific<\/td><td class=\"column-2\">Quantstudio 5<\/td>\n<\/tr>\n<tr class=\"row-9\">\n\t<td class=\"column-1\">Bio-Rad<\/td><td class=\"column-2\">CFX96 (x2)<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-28 from cache --><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"bae7\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"7\" aria-controls=\"elementor-tab-content-1537\"><span class=\"eael-accordion-tab-title\">7.\tIst es m\u00f6glich, die R\u00e4umlichkeiten von BIOMEX zu besichtigen?<\/span><i aria-hidden=\"true\" class=\"fa-toggle icon icon-signet-right-colored\"><\/i><\/div><div id=\"elementor-tab-content-1537\" class=\"eael-accordion-content clearfix\" data-tab=\"7\" aria-labelledby=\"bae7\"><p>Selbstverst\u00e4ndlich. Wir verfolgen eine \u201eOpen-Door-Policy\u201c und freuen uns, Ihnen unsere Infrastruktur vor Ort zu zeigen.<\/p><\/div>\n\t\t\t\t\t<\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"2-leistungsbewertungsstudien\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"2\" aria-controls=\"elementor-tab-content-2402\"><span class=\"eael-advanced-accordion-icon-closed\"><i aria-hidden=\"true\" class=\"fa-accordion-icon fas fa-plus\"><\/i><\/span><span class=\"eael-advanced-accordion-icon-opened\"><i aria-hidden=\"true\" class=\"fa-accordion-icon fas fa-minus\"><\/i><\/span><h2 class=\"eael-accordion-tab-title\">2. Leistungsbewertungsstudien<\/h2><i aria-hidden=\"true\" class=\"fa-toggle icon icon-signet-right-colored\"><\/i><\/div><div id=\"elementor-tab-content-2402\" class=\"eael-accordion-content clearfix\" data-tab=\"2\" aria-labelledby=\"2-leistungsbewertungsstudien\"><style>.elementor-19532 .elementor-element.elementor-element-2c934c6a{padding:5% 0% 5% 0%;}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion, .elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-accordion_media-wrapper{border-style:none;}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .eael-accordion-tab-title, \n                .elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-accordion_media-wrapper .eael-accordion_media-list .eael-accordion_media-content .eael-accordion_media-title{font-family:\"Montserrat\", Sans-serif;font-size:21px;font-weight:700;line-height:1.2em;}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .fa-accordion-icon{font-size:7px;color:#333;}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header svg.fa-accordion-icon{height:7px;width:7px;line-height:7px;}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-accordion_media-list .eael-accordion_media-icon i{font-size:7px;}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-accordion_media-list .eael-accordion_media-icon svg{height:7px;width:7px;line-height:7px;}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .fa-accordion-icon,\n                    .elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-accordion_media-wrapper .eael-accordion_media-lists .eael-accordion_media-list{gap:10px;}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header, \n                .elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-accordion_media-wrapper .eael-accordion_media-list{background-color:#02010100;}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .eael-accordion-tab-title{color:var( --e-global-color-text );}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-accordion_media-content .eael-accordion_media-title{color:var( --e-global-color-text );}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .fa-accordion-icon-svg svg{color:#333;fill:#333;}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header svg{fill:#333;}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-accordion_media-list .eael-accordion_media-icon{color:#333;}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header,\n                .elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-accordion_media-wrapper .eael-accordion_media-lists .eael-accordion_media-list{border-style:solid;border-width:0px 0px 1px 0px;border-color:var( --e-global-color-primary );}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header:hover .eael-accordion-tab-title,\n                    .elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-accordion_media-list:not(.active):hover .eael-accordion_media-title{color:var( --e-global-color-primary );}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header:hover .fa-accordion-icon{color:var( --e-global-color-primary );}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header:hover .fa-accordion-icon svg{color:var( --e-global-color-primary );fill:var( --e-global-color-primary );}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header:hover svg.fa-accordion-icon{fill:var( --e-global-color-primary );}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-accordion_media-list:hover .eael-accordion_media-icon i{color:var( --e-global-color-primary );}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-accordion_media-list:hover .eael-accordion_media-icon svg{fill:var( --e-global-color-primary );}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active, \n                .elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-accordion_media-wrapper .eael-accordion_media-list.active{background-color:#FFFFFF00;}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active{color:var( --e-global-color-primary );}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active .eael-accordion-tab-title{color:var( --e-global-color-primary );}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active .fa-accordion-icon{color:var( --e-global-color-primary );}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active .fa-accordion-icon svg{color:var( --e-global-color-primary );fill:var( --e-global-color-primary );}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active svg.fa-accordion-icon{fill:var( --e-global-color-primary );}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-accordion_media-list.active .eael-accordion_media-icon i{color:var( --e-global-color-primary );}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-accordion_media-list.active .eael-accordion_media-icon svg{fill:var( --e-global-color-primary );}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-content{color:#333;}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-accordion_media-list .eael-accordion_media-content .eael-accordion_media-description{color:#333;}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-content,\n                .elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-accordion_media-list .eael-accordion_media-content .eael-accordion_media-description{font-family:var( --e-global-typography-text-font-family ), Sans-serif;font-size:var( --e-global-typography-text-font-size );font-weight:var( --e-global-typography-text-font-weight );line-height:var( --e-global-typography-text-line-height );letter-spacing:var( --e-global-typography-text-letter-spacing );border-style:none;}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .fa-toggle, .elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header > .fa-toggle-svg{font-size:26px;}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header svg.fa-toggle{height:26px;width:26px;line-height:26px;fill:#444;}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .fa-toggle{color:#444;}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .fa-toggle svg{color:#444;fill:#444;}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list:hover .eael-accordion-header .fa-toggle{color:var( --e-global-color-63a7be9 );}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list:hover .eael-accordion-header .fa-toggle svg{color:var( --e-global-color-63a7be9 );fill:var( --e-global-color-63a7be9 );}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list:hover .eael-accordion-header svg.fa-toggle{fill:var( --e-global-color-63a7be9 );}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active .fa-toggle{color:var( --e-global-color-63a7be9 );}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active .fa-toggle svg{color:var( --e-global-color-63a7be9 );fill:var( --e-global-color-63a7be9 );}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active svg.fa-toggle{fill:var( --e-global-color-63a7be9 );}@media(max-width:1300px){.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-content,\n                .elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-accordion_media-list .eael-accordion_media-content .eael-accordion_media-description{font-size:var( --e-global-typography-text-font-size );line-height:var( --e-global-typography-text-line-height );letter-spacing:var( --e-global-typography-text-letter-spacing );}}@media(max-width:1024px){.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-content,\n                .elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-accordion_media-list .eael-accordion_media-content .eael-accordion_media-description{font-size:var( --e-global-typography-text-font-size );line-height:var( --e-global-typography-text-line-height );letter-spacing:var( --e-global-typography-text-letter-spacing );}}@media(max-width:767px){.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .eael-accordion-tab-title, \n                .elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-accordion_media-wrapper .eael-accordion_media-list .eael-accordion_media-content .eael-accordion_media-title{font-size:20px;}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-content,\n                .elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-accordion_media-list .eael-accordion_media-content .eael-accordion_media-description{font-size:var( --e-global-typography-text-font-size );line-height:var( --e-global-typography-text-line-height );letter-spacing:var( --e-global-typography-text-letter-spacing );}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .fa-toggle, .elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header > .fa-toggle-svg{font-size:0px;}.elementor-19532 .elementor-element.elementor-element-43ae73b7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header svg.fa-toggle{height:0px;width:0px;line-height:0px;}}<\/style>\t\t<div data-elementor-type=\"section\" data-elementor-id=\"19532\" class=\"elementor elementor-19532 elementor-14024 elementor-14024\" data-elementor-post-type=\"elementor_library\">\n\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-2c934c6a elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2c934c6a\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-ac13c5e\" data-id=\"ac13c5e\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-66f6320e elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"66f6320e\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-431d0664\" data-id=\"431d0664\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-43ae73b7 elementor-widget elementor-widget-eael-adv-accordion\" data-id=\"43ae73b7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"eael-adv-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t            <div class=\"eael-adv-accordion\" id=\"eael-adv-accordion-43ae73b7\" data-scroll-on-click=\"no\" data-scroll-speed=\"300\" data-accordion-id=\"43ae73b7\" data-accordion-type=\"accordion\" data-toogle-speed=\"300\">\n            <div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"pes1\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"1\" aria-controls=\"elementor-tab-content-1131\"><span class=\"eael-accordion-tab-title\">1.\tWelche Arten von Leistungsbewertungsstudien bietet BIOMEX an?<\/span><i aria-hidden=\"true\" class=\"fa-toggle icon icon-signet-right-colored\"><\/i><\/div><div id=\"elementor-tab-content-1131\" class=\"eael-accordion-content clearfix\" data-tab=\"1\" aria-labelledby=\"pes1\"><p>Neben klinischen und analytischen Leistungsstudien k\u00f6nnen Sie mit uns auch die Bewertung von patientennahen Testverfahren (Near-Patient Testing, NPT) bzw. Point-of-Care-Tests (POCT), Selbsttests f\u00fcr Laien sowie CLIA-Assays durchf\u00fchren.<\/p>\n<table id=\"tablepress-29\" class=\"tablepress tablepress-id-29\">\n<thead>\n<tr class=\"row-1\">\n\t<th class=\"column-1\">Study Types<\/th><th class=\"column-2\">How we work<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-striping row-hover\">\n<tr class=\"row-2\">\n\t<td class=\"column-1\">Clinical performance evaluation studies<\/td><td class=\"column-2\">We operate our own donation centers. This enables the sourcing of positive and negative samples for the evaluation of diagnostic sensitivity and specificity, as well as for the majority of common analytes.<\/td>\n<\/tr>\n<tr class=\"row-3\">\n\t<td class=\"column-1\">Analytical performance evaluation studies<\/td><td class=\"column-2\">We perform full validation studies for IVDs (qualitative or quantitative) according to the relevant CLSI guidelines. This includes analytical sensitivity (limit of detection, limit of quantification), analytical specificity, stability of the assay or sample, trueness, precision, accuracy, linearity, measuring range, and cut-off value.<\/td>\n<\/tr>\n<tr class=\"row-4\">\n\t<td class=\"column-1\">Laymen studies, Near-patient testing \/ Point-of-care testing<\/td><td class=\"column-2\">Through our own test centers, we can effectively recruit lay people to participate in usability\/laymen studies or NPT\/POCT studies.<\/td>\n<\/tr>\n<tr class=\"row-5\">\n\t<td class=\"column-1\">Studies for the validation of CLIA-assays<\/td><td class=\"column-2\">Our infrastructure is capable of performing tests with class D IVDs (e.g., HIV) as well as class C and B IVDs in accordance with the EU common specifications. We have dedicated facilities and instruments for reference testing to routinely perform these validation studies in-house.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-29 from cache --><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"pes2\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"2\" aria-controls=\"elementor-tab-content-1132\"><span class=\"eael-accordion-tab-title\">2.\tDeckt BIOMEX den gesamten Workflow ab?<\/span><i aria-hidden=\"true\" class=\"fa-toggle icon icon-signet-right-colored\"><\/i><\/div><div id=\"elementor-tab-content-1132\" class=\"eael-accordion-content clearfix\" data-tab=\"2\" aria-labelledby=\"pes2\"><p>Ja, im Gegensatz zu vielen anderen Auftragsforschungsinstituten (CROs) bieten wir einen umfassenden Full-Service an. Dieser umfasst das Studiendesign, alle damit verbundenen Fachberatungen durch unsere Experten, die Beschaffung und Aufbereitung aller notwendigen Proben, die Durchf\u00fchrung der Tests in unseren eigenen Laboren sowie die Datenanalyse und Erstellung des Abschlussberichts.<\/p><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"pes3\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"3\" aria-controls=\"elementor-tab-content-1133\"><span class=\"eael-accordion-tab-title\">3.\tWie erhalte ich ein konkretes Angebot f\u00fcr meine Anfrage?<\/span><i aria-hidden=\"true\" class=\"fa-toggle icon icon-signet-right-colored\"><\/i><\/div><div id=\"elementor-tab-content-1133\" class=\"eael-accordion-content clearfix\" data-tab=\"3\" aria-labelledby=\"pes3\"><p>Bitte wenden Sie sich an unser Vertriebsteam unter <a href=\"mailto:sales@biomex.de\"><span style=\"text-decoration: underline\"><strong>sales@biomex.de<\/strong><\/span><\/a>. Unsere Experten f\u00fchren Sie durch unseren standardisierten Anfrageprozess.<\/p><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"pes4\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"4\" aria-controls=\"elementor-tab-content-1134\"><span class=\"eael-accordion-tab-title\">4.\tWie lange dauert eine Leistungsbewertungsstudie in der Regel?<\/span><i aria-hidden=\"true\" class=\"fa-toggle icon icon-signet-right-colored\"><\/i><\/div><div id=\"elementor-tab-content-1134\" class=\"eael-accordion-content clearfix\" data-tab=\"4\" aria-labelledby=\"pes4\"><p>Die Studiendauer h\u00e4ngt von verschiedenen Faktoren ab, z.\u202fB. von der Art der Studie und der Probe, dem Stichprobenumfang, dem f\u00fcr die Probengewinnung erforderlichen Zeitraum (z.\u202fB. durch Inzidenzen und saisonale Ereignisse bei prospektiven Sammlungen), der Dauer der Ethikvotum-Einholung sowie dem zeitlichen Aufwand f\u00fcr das Studien-Setup. Dank unserer langj\u00e4hrigen Erfahrung k\u00f6nnen wir Ihnen in der Regel vorab eine fundierte Sch\u00e4tzung geben.<\/p><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"pes5\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"5\" aria-controls=\"elementor-tab-content-1135\"><span class=\"eael-accordion-tab-title\">5.\tF\u00fchrt BIOMEX auch Untersuchungen zur wissenschaftlichen Validit\u00e4t durch?<\/span><i aria-hidden=\"true\" class=\"fa-toggle icon icon-signet-right-colored\"><\/i><\/div><div id=\"elementor-tab-content-1135\" class=\"eael-accordion-content clearfix\" data-tab=\"5\" aria-labelledby=\"pes5\"><p>Grunds\u00e4tzlich f\u00fchren wir keine eigenst\u00e4ndige Forschung zur wissenschaftlichen Validit\u00e4t durch, es sei denn, dies ist Bestandteil eines Gesamtpakets, das wissenschaftliche Validit\u00e4t, analytische Leistungsbewertung und klinische Leistungsbewertung umfasst.<\/p><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"pes6\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"6\" aria-controls=\"elementor-tab-content-1136\"><span class=\"eael-accordion-tab-title\">6.\tK\u00f6nnen Studien mit prospektiv gesammelten Frischproben durchgef\u00fchrt werden?<\/span><i aria-hidden=\"true\" class=\"fa-toggle icon icon-signet-right-colored\"><\/i><\/div><div id=\"elementor-tab-content-1136\" class=\"eael-accordion-content clearfix\" data-tab=\"6\" aria-labelledby=\"pes6\"><p>Ja, zus\u00e4tzlich zu unserer umfangreichen Biobank mit retrospektiv gesammelten Proben verf\u00fcgen wir \u00fcber die erforderliche Infrastruktur zur Gewinnung frischer Humanproben. Dies umfasst die Rekrutierung von Studienteilnehmenden sowie die Einholung der erforderlichen Ethikvoten durch eine Ethikkommission (IRB).<\/p><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"pes7\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"7\" aria-controls=\"elementor-tab-content-1137\"><span class=\"eael-accordion-tab-title\">7.\tWelche klinischen Informationen sind bei prospektiv gesammelten Proben verf\u00fcgbar?<\/span><i aria-hidden=\"true\" class=\"fa-toggle icon icon-signet-right-colored\"><\/i><\/div><div id=\"elementor-tab-content-1137\" class=\"eael-accordion-content clearfix\" data-tab=\"7\" aria-labelledby=\"pes7\"><p>Je nach Studienanforderung k\u00f6nnen die \u00fcblichen klinischen Informationen der Spender erfasst werden, z.\u202fB. Alter, Geschlecht, Zeitpunkt\/Datum der Probenentnahme, Erstdiagnose, Symptome und Symptombeginn, Angaben zu Kontaktpersonen und\/oder Impfstatus, ICD-Code (sofern dies nicht gegen Anonymisierungsanforderungen verst\u00f6\u00dft). Eine prospektive Sammlung nicht anonymisierter Proben ist ebenfalls m\u00f6glich \u2013 unter Einbindung klinischer Kooperationspartner und nach Vorlage eines positiven Ethikvotums.<\/p><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"pes8\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"8\" aria-controls=\"elementor-tab-content-1138\"><span class=\"eael-accordion-tab-title\">8.\tWir sind ein verl\u00e4sslicher Partner f\u00fcr Zulassungsantr\u00e4ge gem\u00e4\u00df IVDR (Europ\u00e4ische Union), TGA (Australien), NMPA (China) sowie den Richtlinien der WHO. Studien \u2013 insbesondere klinische \u2013 f\u00fcr FDA-Zulassungen (USA) bieten wir nicht an.<\/span><i aria-hidden=\"true\" class=\"fa-toggle icon icon-signet-right-colored\"><\/i><\/div><div id=\"elementor-tab-content-1138\" class=\"eael-accordion-content clearfix\" data-tab=\"8\" aria-labelledby=\"pes8\"><p>Wir sind ein verl\u00e4sslicher Partner f\u00fcr Zulassungsantr\u00e4ge gem\u00e4\u00df IVDR (Europ\u00e4ische Union), TGA (Australien), NMPA (China) sowie den Richtlinien der WHO. Studien \u2013 insbesondere klinische \u2013 f\u00fcr FDA-Zulassungen (USA) bieten wir nicht an.<\/p><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"pes9\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"9\" aria-controls=\"elementor-tab-content-1139\"><span class=\"eael-accordion-tab-title\">9.\tWir suchen eine Benannte Stelle in Europa \u2013 kann BIOMEX hierbei unterst\u00fctzen?<\/span><i aria-hidden=\"true\" class=\"fa-toggle icon icon-signet-right-colored\"><\/i><\/div><div id=\"elementor-tab-content-1139\" class=\"eael-accordion-content clearfix\" data-tab=\"9\" aria-labelledby=\"pes9\"><p>Wir beraten nicht direkt bei der Auswahl einer Benannten Stelle, vermitteln Sie jedoch gerne an einen unserer vertrauensw\u00fcrdigen Partner weiter. Bitte wenden Sie sich hierzu an <a href=\"mailto:sales@biomex.de\"><span style=\"text-decoration: underline\"><strong>sales@biomex.de.<\/strong><\/span><\/a><\/p><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"pes10\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"10\" aria-controls=\"elementor-tab-content-11310\"><span class=\"eael-accordion-tab-title\">10.\tWir suchen einen EU-Bevollm\u00e4chtigten \u2013 kann BIOMEX hierbei unterst\u00fctzen?<\/span><i aria-hidden=\"true\" class=\"fa-toggle icon icon-signet-right-colored\"><\/i><\/div><div id=\"elementor-tab-content-11310\" class=\"eael-accordion-content clearfix\" data-tab=\"10\" aria-labelledby=\"pes10\"><p>Wir agieren nicht als gesetzlicher Bevollm\u00e4chtigter, stellen aber gerne den Kontakt zu einem unserer vertrauensvollen Partner her. Bitte kontaktieren Sie uns unter <a href=\"mailto:sales@biomex.de\"><span style=\"text-decoration: underline\"><strong>sales@biomex.de<\/strong><\/span><\/a>.<\/p><\/div>\n\t\t\t\t\t<\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"3-qualitt-und-ethik\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"3\" aria-controls=\"elementor-tab-content-2403\"><span class=\"eael-advanced-accordion-icon-closed\"><i aria-hidden=\"true\" class=\"fa-accordion-icon fas fa-plus\"><\/i><\/span><span class=\"eael-advanced-accordion-icon-opened\"><i aria-hidden=\"true\" class=\"fa-accordion-icon fas fa-minus\"><\/i><\/span><h2 class=\"eael-accordion-tab-title\">3. Qualit\u00e4t und Ethik<\/h2><i aria-hidden=\"true\" class=\"fa-toggle icon icon-signet-right-colored\"><\/i><\/div><div id=\"elementor-tab-content-2403\" class=\"eael-accordion-content clearfix\" data-tab=\"3\" aria-labelledby=\"3-qualitt-und-ethik\"><style>.elementor-19535 .elementor-element.elementor-element-364321fa{transition:background 0.3s, border 0.3s, border-radius 0.3s, box-shadow 0.3s;padding:5% 0% 5% 0%;}.elementor-19535 .elementor-element.elementor-element-364321fa > .elementor-background-overlay{transition:background 0.3s, border-radius 0.3s, opacity 0.3s;}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion, .elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-accordion_media-wrapper{border-style:none;}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .eael-accordion-tab-title, \n                .elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-accordion_media-wrapper .eael-accordion_media-list .eael-accordion_media-content .eael-accordion_media-title{font-family:\"Montserrat\", Sans-serif;font-size:21px;font-weight:700;line-height:1.2em;}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .fa-accordion-icon{font-size:7px;color:#333;}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header svg.fa-accordion-icon{height:7px;width:7px;line-height:7px;}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-accordion_media-list .eael-accordion_media-icon i{font-size:7px;}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-accordion_media-list .eael-accordion_media-icon svg{height:7px;width:7px;line-height:7px;}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .fa-accordion-icon,\n                    .elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-accordion_media-wrapper .eael-accordion_media-lists .eael-accordion_media-list{gap:10px;}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header, \n                .elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-accordion_media-wrapper .eael-accordion_media-list{background-color:#02010100;}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .eael-accordion-tab-title{color:var( --e-global-color-text );}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-accordion_media-content .eael-accordion_media-title{color:var( --e-global-color-text );}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .fa-accordion-icon-svg svg{color:#333;fill:#333;}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header svg{fill:#333;}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-accordion_media-list .eael-accordion_media-icon{color:#333;}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header,\n                .elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-accordion_media-wrapper .eael-accordion_media-lists .eael-accordion_media-list{border-style:solid;border-width:0px 0px 1px 0px;border-color:var( --e-global-color-primary );}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header:hover .eael-accordion-tab-title,\n                    .elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-accordion_media-list:not(.active):hover .eael-accordion_media-title{color:var( --e-global-color-primary );}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header:hover .fa-accordion-icon{color:var( --e-global-color-primary );}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header:hover .fa-accordion-icon svg{color:var( --e-global-color-primary );fill:var( --e-global-color-primary );}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header:hover svg.fa-accordion-icon{fill:var( --e-global-color-primary );}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-accordion_media-list:hover .eael-accordion_media-icon i{color:var( --e-global-color-primary );}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-accordion_media-list:hover .eael-accordion_media-icon svg{fill:var( --e-global-color-primary );}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active, \n                .elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-accordion_media-wrapper .eael-accordion_media-list.active{background-color:#FFFFFF00;}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active{color:var( --e-global-color-primary );}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active .eael-accordion-tab-title{color:var( --e-global-color-primary );}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active .fa-accordion-icon{color:var( --e-global-color-primary );}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active .fa-accordion-icon svg{color:var( --e-global-color-primary );fill:var( --e-global-color-primary );}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active svg.fa-accordion-icon{fill:var( --e-global-color-primary );}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-accordion_media-list.active .eael-accordion_media-icon i{color:var( --e-global-color-primary );}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-accordion_media-list.active .eael-accordion_media-icon svg{fill:var( --e-global-color-primary );}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-content{color:#333;}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-accordion_media-list .eael-accordion_media-content .eael-accordion_media-description{color:#333;}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-content,\n                .elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-accordion_media-list .eael-accordion_media-content .eael-accordion_media-description{font-family:var( --e-global-typography-text-font-family ), Sans-serif;font-size:var( --e-global-typography-text-font-size );font-weight:var( --e-global-typography-text-font-weight );line-height:var( --e-global-typography-text-line-height );letter-spacing:var( --e-global-typography-text-letter-spacing );border-style:none;}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .fa-toggle, .elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header > .fa-toggle-svg{font-size:26px;}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header svg.fa-toggle{height:26px;width:26px;line-height:26px;fill:#444;}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .fa-toggle{color:#444;}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .fa-toggle svg{color:#444;fill:#444;}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list:hover .eael-accordion-header .fa-toggle{color:var( --e-global-color-63a7be9 );}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list:hover .eael-accordion-header .fa-toggle svg{color:var( --e-global-color-63a7be9 );fill:var( --e-global-color-63a7be9 );}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list:hover .eael-accordion-header svg.fa-toggle{fill:var( --e-global-color-63a7be9 );}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active .fa-toggle{color:var( --e-global-color-63a7be9 );}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active .fa-toggle svg{color:var( --e-global-color-63a7be9 );fill:var( --e-global-color-63a7be9 );}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active svg.fa-toggle{fill:var( --e-global-color-63a7be9 );}@media(max-width:1300px){.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-content,\n                .elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-accordion_media-list .eael-accordion_media-content .eael-accordion_media-description{font-size:var( --e-global-typography-text-font-size );line-height:var( --e-global-typography-text-line-height );letter-spacing:var( --e-global-typography-text-letter-spacing );}}@media(max-width:1024px){.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-content,\n                .elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-accordion_media-list .eael-accordion_media-content .eael-accordion_media-description{font-size:var( --e-global-typography-text-font-size );line-height:var( --e-global-typography-text-line-height );letter-spacing:var( --e-global-typography-text-letter-spacing );}}@media(max-width:767px){.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .eael-accordion-tab-title, \n                .elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-accordion_media-wrapper .eael-accordion_media-list .eael-accordion_media-content .eael-accordion_media-title{font-size:20px;}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-content,\n                .elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-accordion_media-list .eael-accordion_media-content .eael-accordion_media-description{font-size:var( --e-global-typography-text-font-size );line-height:var( --e-global-typography-text-line-height );letter-spacing:var( --e-global-typography-text-letter-spacing );}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .fa-toggle, .elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header > .fa-toggle-svg{font-size:0px;}.elementor-19535 .elementor-element.elementor-element-2aee68c7 .eael-adv-accordion .eael-accordion-list .eael-accordion-header svg.fa-toggle{height:0px;width:0px;line-height:0px;}}<\/style>\t\t<div data-elementor-type=\"section\" data-elementor-id=\"19535\" class=\"elementor elementor-19535 elementor-14033 elementor-14033\" data-elementor-post-type=\"elementor_library\">\n\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-364321fa elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"364321fa\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-5cbbd251\" data-id=\"5cbbd251\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2aee68c7 elementor-widget elementor-widget-eael-adv-accordion\" data-id=\"2aee68c7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"eael-adv-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t            <div class=\"eael-adv-accordion\" id=\"eael-adv-accordion-2aee68c7\" data-scroll-on-click=\"no\" data-scroll-speed=\"300\" data-accordion-id=\"2aee68c7\" data-accordion-type=\"accordion\" data-toogle-speed=\"300\">\n            <div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"qae1\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"1\" aria-controls=\"elementor-tab-content-7201\"><span class=\"eael-accordion-tab-title\">1.\tWas beinhaltet die Qualit\u00e4tspolitik von BIOMEX?<\/span><i aria-hidden=\"true\" class=\"fa-toggle icon icon-signet-right-colored\"><\/i><\/div><div id=\"elementor-tab-content-7201\" class=\"eael-accordion-content clearfix\" data-tab=\"1\" aria-labelledby=\"qae1\"><p>Unsere Gesch\u00e4ftst\u00e4tigkeit orientiert sich an den Anforderungen unserer Kunden sowie an den geltenden gesetzlichen Vorgaben und wird durch unsere Verantwortung gegen\u00fcber Gesellschaft und Umwelt geleitet. Wir entwickeln und liefern qualitativ hochwertige Produkte auf dem neuesten Stand von Wissenschaft und Technik und bieten einen umfassenden Service. Grundlage unseres Handelns sind Zuverl\u00e4ssigkeit und Kundenorientierung. Unser Ziel ist die Fehlervermeidung anstelle nachtr\u00e4glicher Fehlerkorrektur. Die Anforderungen unseres Qualit\u00e4tsmanagementsystems werden konsequent erf\u00fcllt, und wir verbessern dessen Wirksamkeit kontinuierlich. Weitere Informationen zu unserer Unternehmensphilosophie finden Sie auf unseren Unternehmensseiten.<\/p><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"qae2\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"2\" aria-controls=\"elementor-tab-content-7202\"><span class=\"eael-accordion-tab-title\">2.\t\u00dcber welche offiziellen Zertifizierungen verf\u00fcgt BIOMEX?<\/span><i aria-hidden=\"true\" class=\"fa-toggle icon icon-signet-right-colored\"><\/i><\/div><div id=\"elementor-tab-content-7202\" class=\"eael-accordion-content clearfix\" data-tab=\"2\" aria-labelledby=\"qae2\"><p>Unser Qualit\u00e4tsmanagementsystem ist nach ISO 9001 zertifiziert. S\u00e4mtliche Studien werden gem\u00e4\u00df ISO 20916:2019 und ISO 14155 durchgef\u00fchrt. Dar\u00fcber hinaus befinden wir uns aktuell im Zertifizierungsprozess nach ISO 17025 f\u00fcr unsere Laboratorien.<\/p><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"qae3\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"3\" aria-controls=\"elementor-tab-content-7203\"><span class=\"eael-accordion-tab-title\">3.\tHolt BIOMEX f\u00fcr alle Studien zur klinischen Leistungsbewertung eine Ethikvotum ein?<\/span><i aria-hidden=\"true\" class=\"fa-toggle icon icon-signet-right-colored\"><\/i><\/div><div id=\"elementor-tab-content-7203\" class=\"eael-accordion-content clearfix\" data-tab=\"3\" aria-labelledby=\"qae3\"><p>Ja, sowohl f\u00fcr invasive als auch f\u00fcr nicht-invasive klinische Probenentnahmen.<\/p><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"qae4\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"4\" aria-controls=\"elementor-tab-content-7204\"><span class=\"eael-accordion-tab-title\">4.\tKann BIOMEX Proben von minderj\u00e4hrigen Spendern in klinische Studien einbeziehen (wenn dies in der IFU gefordert ist)?<\/span><i aria-hidden=\"true\" class=\"fa-toggle icon icon-signet-right-colored\"><\/i><\/div><div id=\"elementor-tab-content-7204\" class=\"eael-accordion-content clearfix\" data-tab=\"4\" aria-labelledby=\"qae4\"><p>F\u00fcr nicht-invasive Testungen liegt eine Ethikgenehmigung f\u00fcr Teilnehmer ab 14 Jahren vor. F\u00fcr invasive Testungen besteht eine Genehmigung ab 18 Jahren. Sollte eine Ethikfreigabe f\u00fcr j\u00fcngere Teilnehmer erforderlich sein, kann diese im Bedarfsfall beantragt werden.<\/p><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"qae5\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"5\" aria-controls=\"elementor-tab-content-7205\"><span class=\"eael-accordion-tab-title\">5.\tMit welchen speziellen Laborger\u00e4ten arbeitet BIOMEX?<\/span><i aria-hidden=\"true\" class=\"fa-toggle icon icon-signet-right-colored\"><\/i><\/div><div id=\"elementor-tab-content-7205\" class=\"eael-accordion-content clearfix\" data-tab=\"5\" aria-labelledby=\"qae5\"><p>Neben standardisierten Laborverfahren bieten wir eine Vielzahl diagnostischer Methoden an, darunter PCR, klinische Chemie, CLIA\/CMIA, POCT und weitere. Unsere Laborausstattung umfasst unter anderem:<\/p>\n<table id=\"tablepress-28-no-2\" class=\"tablepress tablepress-id-28\">\n<thead>\n<tr class=\"row-1\">\n\t<th class=\"column-1\">Company<\/th><th class=\"column-2\">Instrument<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-striping row-hover\">\n<tr class=\"row-2\">\n\t<td class=\"column-1\">Roche<\/td><td class=\"column-2\">Cobas e411<\/td>\n<\/tr>\n<tr class=\"row-3\">\n\t<td class=\"column-1\">Roche<\/td><td class=\"column-2\">Cobas c501<\/td>\n<\/tr>\n<tr class=\"row-4\">\n\t<td class=\"column-1\">Roche<\/td><td class=\"column-2\">Cobas 5800<\/td>\n<\/tr>\n<tr class=\"row-5\">\n\t<td class=\"column-1\">Abbott<\/td><td class=\"column-2\">Architect i1000SR<\/td>\n<\/tr>\n<tr class=\"row-6\">\n\t<td class=\"column-1\">Diasorin<\/td><td class=\"column-2\">Liason XL<\/td>\n<\/tr>\n<tr class=\"row-7\">\n\t<td class=\"column-1\">BioM\u00e9rieux<\/td><td class=\"column-2\">MiniVidas<\/td>\n<\/tr>\n<tr class=\"row-8\">\n\t<td class=\"column-1\">ThermoScientific<\/td><td class=\"column-2\">Quantstudio 5<\/td>\n<\/tr>\n<tr class=\"row-9\">\n\t<td class=\"column-1\">Bio-Rad<\/td><td class=\"column-2\">CFX96 (x2)<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-28-no-2 from cache --><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"qae6\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"6\" aria-controls=\"elementor-tab-content-7206\"><span class=\"eael-accordion-tab-title\">6.\tWas ist das Alleinstellungsmerkmal (USP) von BIOMEX als Auftragsforschungsinstitut (CRO) f\u00fcr diagnostische Produkte?<\/span><i aria-hidden=\"true\" class=\"fa-toggle icon icon-signet-right-colored\"><\/i><\/div><div id=\"elementor-tab-content-7206\" class=\"eael-accordion-content clearfix\" data-tab=\"6\" aria-labelledby=\"qae6\"><p>Auftragsforschungsinstitut (CRO) f\u00fcr diagnostische Produkte?<br \/>Unsere Leistungen zeichnen sich unter anderem durch folgende Aspekte aus, die uns von anderen CROs unterscheiden und eine Durchf\u00fchrung Ihrer Leistungsbewertungsstudie mit h\u00f6chster Flexibilit\u00e4t und Qualit\u00e4t erm\u00f6glichen:<\/p><ul><li>Probengewinnung in unseren eigenen Spendezentren \u2013 prospektiv und exakt auf Ihre individuellen Anforderungen zugeschnitten<\/li><li>Europas gr\u00f6\u00dftes kommerzielles Biospezimen-Archiv<\/li><\/ul><p>100 % der Wertsch\u00f6pfungskette im eigenen Haus, einschlie\u00dflich regulatorischer Expertise, Studiendesign, Ethikvoten, Labortests, Materialhandling und Management externer Studienzentren<\/p><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"qae7\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"7\" aria-controls=\"elementor-tab-content-7207\"><span class=\"eael-accordion-tab-title\">7.\tIst ein Besuch der BIOMEX-Einrichtungen m\u00f6glich?<\/span><i aria-hidden=\"true\" class=\"fa-toggle icon icon-signet-right-colored\"><\/i><\/div><div id=\"elementor-tab-content-7207\" class=\"eael-accordion-content clearfix\" data-tab=\"7\" aria-labelledby=\"qae7\"><p>Selbstverst\u00e4ndlich. Wir pflegen eine \u201eOpen-Door-Policy\u201c und zeigen Ihnen unsere Infrastruktur gerne vor Ort.<\/p><\/div>\n\t\t\t\t\t<\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"4-in-vitro-diagnostika-verordnung-ivdr\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"4\" aria-controls=\"elementor-tab-content-2404\"><span class=\"eael-advanced-accordion-icon-closed\"><i aria-hidden=\"true\" class=\"fa-accordion-icon fas fa-plus\"><\/i><\/span><span class=\"eael-advanced-accordion-icon-opened\"><i aria-hidden=\"true\" class=\"fa-accordion-icon fas fa-minus\"><\/i><\/span><h2 class=\"eael-accordion-tab-title\">4. In-vitro-Diagnostika-Verordnung (IVDR)<\/h2><i aria-hidden=\"true\" class=\"fa-toggle icon icon-signet-right-colored\"><\/i><\/div><div id=\"elementor-tab-content-2404\" class=\"eael-accordion-content clearfix\" data-tab=\"4\" aria-labelledby=\"4-in-vitro-diagnostika-verordnung-ivdr\"><style>.elementor-19538 .elementor-element.elementor-element-1b2630ee{padding:5% 0% 5% 0%;}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion, .elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-accordion_media-wrapper{border-style:none;}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .eael-accordion-tab-title, \n                .elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-accordion_media-wrapper .eael-accordion_media-list .eael-accordion_media-content .eael-accordion_media-title{font-family:\"Montserrat\", Sans-serif;font-size:21px;font-weight:700;line-height:1.2em;}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .fa-accordion-icon{font-size:7px;color:#333;}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-header svg.fa-accordion-icon{height:7px;width:7px;line-height:7px;}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-accordion_media-list .eael-accordion_media-icon i{font-size:7px;}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-accordion_media-list .eael-accordion_media-icon svg{height:7px;width:7px;line-height:7px;}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .fa-accordion-icon,\n                    .elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-accordion_media-wrapper .eael-accordion_media-lists .eael-accordion_media-list{gap:10px;}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-header, \n                .elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-accordion_media-wrapper .eael-accordion_media-list{background-color:#02010100;}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .eael-accordion-tab-title{color:var( --e-global-color-text );}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-accordion_media-content .eael-accordion_media-title{color:var( --e-global-color-text );}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .fa-accordion-icon-svg svg{color:#333;fill:#333;}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-header svg{fill:#333;}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-accordion_media-list .eael-accordion_media-icon{color:#333;}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-header,\n                .elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-accordion_media-wrapper .eael-accordion_media-lists .eael-accordion_media-list{border-style:solid;border-width:0px 0px 1px 0px;border-color:var( --e-global-color-primary );}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-header:hover .eael-accordion-tab-title,\n                    .elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-accordion_media-list:not(.active):hover .eael-accordion_media-title{color:var( --e-global-color-primary );}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-header:hover .fa-accordion-icon{color:var( --e-global-color-primary );}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-header:hover .fa-accordion-icon svg{color:var( --e-global-color-primary );fill:var( --e-global-color-primary );}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-header:hover svg.fa-accordion-icon{fill:var( --e-global-color-primary );}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-accordion_media-list:hover .eael-accordion_media-icon i{color:var( --e-global-color-primary );}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-accordion_media-list:hover .eael-accordion_media-icon svg{fill:var( --e-global-color-primary );}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active, \n                .elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-accordion_media-wrapper .eael-accordion_media-list.active{background-color:#FFFFFF00;}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active{color:var( --e-global-color-primary );}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active .eael-accordion-tab-title{color:var( --e-global-color-primary );}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active .fa-accordion-icon{color:var( --e-global-color-primary );}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active .fa-accordion-icon svg{color:var( --e-global-color-primary );fill:var( --e-global-color-primary );}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active svg.fa-accordion-icon{fill:var( --e-global-color-primary );}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-accordion_media-list.active .eael-accordion_media-icon i{color:var( --e-global-color-primary );}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-accordion_media-list.active .eael-accordion_media-icon svg{fill:var( --e-global-color-primary );}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-content{color:#333;}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-accordion_media-list .eael-accordion_media-content .eael-accordion_media-description{color:#333;}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-content,\n                .elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-accordion_media-list .eael-accordion_media-content .eael-accordion_media-description{font-family:var( --e-global-typography-text-font-family ), Sans-serif;font-size:var( --e-global-typography-text-font-size );font-weight:var( --e-global-typography-text-font-weight );line-height:var( --e-global-typography-text-line-height );letter-spacing:var( --e-global-typography-text-letter-spacing );border-style:none;}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .fa-toggle, .elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-header > .fa-toggle-svg{font-size:26px;}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-header svg.fa-toggle{height:26px;width:26px;line-height:26px;fill:#444;}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .fa-toggle{color:#444;}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .fa-toggle svg{color:#444;fill:#444;}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list:hover .eael-accordion-header .fa-toggle{color:var( --e-global-color-63a7be9 );}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list:hover .eael-accordion-header .fa-toggle svg{color:var( --e-global-color-63a7be9 );fill:var( --e-global-color-63a7be9 );}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list:hover .eael-accordion-header svg.fa-toggle{fill:var( --e-global-color-63a7be9 );}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active .fa-toggle{color:var( --e-global-color-63a7be9 );}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active .fa-toggle svg{color:var( --e-global-color-63a7be9 );fill:var( --e-global-color-63a7be9 );}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-header.active svg.fa-toggle{fill:var( --e-global-color-63a7be9 );}@media(max-width:1300px){.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-content,\n                .elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-accordion_media-list .eael-accordion_media-content .eael-accordion_media-description{font-size:var( --e-global-typography-text-font-size );line-height:var( --e-global-typography-text-line-height );letter-spacing:var( --e-global-typography-text-letter-spacing );}}@media(max-width:1024px){.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-content,\n                .elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-accordion_media-list .eael-accordion_media-content .eael-accordion_media-description{font-size:var( --e-global-typography-text-font-size );line-height:var( --e-global-typography-text-line-height );letter-spacing:var( --e-global-typography-text-letter-spacing );}}@media(max-width:767px){.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .eael-accordion-tab-title, \n                .elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-accordion_media-wrapper .eael-accordion_media-list .eael-accordion_media-content .eael-accordion_media-title{font-size:20px;}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-content,\n                .elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-accordion_media-list .eael-accordion_media-content .eael-accordion_media-description{font-size:var( --e-global-typography-text-font-size );line-height:var( --e-global-typography-text-line-height );letter-spacing:var( --e-global-typography-text-letter-spacing );}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-header .fa-toggle, .elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-header > .fa-toggle-svg{font-size:0px;}.elementor-19538 .elementor-element.elementor-element-5e5def55 .eael-adv-accordion .eael-accordion-list .eael-accordion-header svg.fa-toggle{height:0px;width:0px;line-height:0px;}}<\/style>\t\t<div data-elementor-type=\"section\" data-elementor-id=\"19538\" class=\"elementor elementor-19538 elementor-14020 elementor-14020\" data-elementor-post-type=\"elementor_library\">\n\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-1b2630ee elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1b2630ee\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-5b136143\" data-id=\"5b136143\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-7dcbd7fb elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7dcbd7fb\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-671b558b\" data-id=\"671b558b\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5e5def55 elementor-widget elementor-widget-eael-adv-accordion\" data-id=\"5e5def55\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"eael-adv-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t            <div class=\"eael-adv-accordion\" id=\"eael-adv-accordion-5e5def55\" data-scroll-on-click=\"no\" data-scroll-speed=\"300\" data-accordion-id=\"5e5def55\" data-accordion-type=\"accordion\" data-toogle-speed=\"300\">\n            <div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"ivdr1\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"1\" aria-controls=\"elementor-tab-content-1581\"><span class=\"eael-accordion-tab-title\">1. Wann trat die europ\u00e4ische In-vitro-Diagnostika-Verordnung (IVDR) in Kraft?<\/span><i aria-hidden=\"true\" class=\"fa-toggle icon icon-signet-right-colored\"><\/i><\/div><div id=\"elementor-tab-content-1581\" class=\"eael-accordion-content clearfix\" data-tab=\"1\" aria-labelledby=\"ivdr1\"><p>Die europ\u00e4ische In-vitro-Diagnostika-Verordnung (IVDR) trat im Mai 2017 in Kraft und ersetzte nach einer \u00dcbergangsfrist von f\u00fcnf Jahren im Mai 2022 die bisher geltende In-vitro-Diagnostika-Richtlinie (IVDD). Bis Mai 2027 werden die Vorgaben der IVDR schrittweise f\u00fcr die jeweiligen Risikoklassen der Produkte verbindlich.<\/p><p><img fetchpriority=\"high\" decoding=\"async\" class=\"aligncenter wp-image-14628 size-full\" src=\"https:\/\/biomex.de\/wp-content\/uploads\/grafik-ivds_2024-2.png\" alt=\"\" width=\"816\" height=\"417\" srcset=\"https:\/\/biomex.de\/wp-content\/uploads\/grafik-ivds_2024-2.png 816w, https:\/\/biomex.de\/wp-content\/uploads\/grafik-ivds_2024-2-300x153.png 300w, https:\/\/biomex.de\/wp-content\/uploads\/grafik-ivds_2024-2-768x392.png 768w\" sizes=\"(max-width: 816px) 100vw, 816px\" \/><\/p><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"ivdr2\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"2\" aria-controls=\"elementor-tab-content-1582\"><span class=\"eael-accordion-tab-title\">2. Was versteht man unter wissenschaftlicher Validit\u00e4t, analytischer Leistung und klinischer Leistung gem\u00e4\u00df IVDR?<\/span><i aria-hidden=\"true\" class=\"fa-toggle icon icon-signet-right-colored\"><\/i><\/div><div id=\"elementor-tab-content-1582\" class=\"eael-accordion-content clearfix\" data-tab=\"2\" aria-labelledby=\"ivdr2\"><p>Die <strong>wissenschaftliche Validit\u00e4t<\/strong> bezeichnet den Zusammenhang zwischen einem Analyten und einem bestimmten klinischen Zustand oder physiologischen Zustand (IVDR, Artikel 2 (38)).<\/p><p>Die <strong>analytische Leistung<\/strong> beschreibt die F\u00e4higkeit eines Produkts, einen spezifischen Analyten korrekt nachzuweisen oder zu messen (IVDR, Artikel 2 (40)).<\/p><p>Die <strong>klinische Leistung<\/strong> bezieht sich auf die F\u00e4higkeit eines Produkts, Ergebnisse zu liefern, die mit einem bestimmten klinischen Zustand oder physiologischen bzw. pathologischen Prozess oder Zustand korrelieren (IVDR, Artikel 2 (41)).<\/p><\/div>\n\t\t\t\t\t<\/div><div class=\"eael-accordion-list\">\n\t\t\t\t\t<div id=\"ivdr3\" class=\"elementor-tab-title eael-accordion-header\" tabindex=\"0\" data-tab=\"3\" aria-controls=\"elementor-tab-content-1583\"><span class=\"eael-accordion-tab-title\">3.\tWas versteht man unter der Leistungsbewertung vor dem Inverkehrbringen und der Leistungsbewertung nach dem Inverkehrbringen gem\u00e4\u00df IVDR?<\/span><i aria-hidden=\"true\" class=\"fa-toggle icon icon-signet-right-colored\"><\/i><\/div><div id=\"elementor-tab-content-1583\" class=\"eael-accordion-content clearfix\" data-tab=\"3\" aria-labelledby=\"ivdr3\"><p>Zur Beurteilung der Leistungsf\u00e4higkeit eines Produkts vor dem Inverkehrbringen m\u00fcssen Hersteller alle verf\u00fcgbaren Daten zum Produkt, zu dessen bestimmungsgem\u00e4\u00dfer Verwendung und zur Sicherheit erfassen und bestehende Datenl\u00fccken schlie\u00dfen. Offene Fragestellungen erfordern die Durchf\u00fchrung geeigneter Leistungsbewertungsstudien (IVDR, Anhang XIII, Teil A, Abschnitt 1.2).<br \/><br \/>Nach dem Inverkehrbringen sollen Hersteller systematisch Leistungs- und wissenschaftliche Daten aus der tats\u00e4chlichen Anwendung des Produkts erfassen und bewerten. Ziel ist es, die Sicherheit, Leistungsf\u00e4higkeit und wissenschaftliche Validit\u00e4t des Produkts \u00fcber dessen gesamte Lebensdauer hinweg zu gew\u00e4hrleisten sowie potenzielle Risiken fr\u00fchzeitig zu erkennen (IVDR, Anhang XIII, Teil B, Abschnitt 4).<\/p><\/div>\n\t\t\t\t\t<\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-3ceb0eb elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3ceb0eb\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-6de3a7d\" data-id=\"6de3a7d\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-ed74e37 elementor-widget elementor-widget-template\" data-id=\"ed74e37\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"template.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-template\">\n\t\t\t\t\t<div data-elementor-type=\"section\" data-elementor-id=\"19594\" class=\"elementor elementor-19594 elementor-12060 elementor-12060\" data-elementor-post-type=\"elementor_library\">\n\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-607aaf75 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"607aaf75\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-5ad696a6\" data-id=\"5ad696a6\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2d6b5132 elementor-widget elementor-widget-spacer\" data-id=\"2d6b5132\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3e39ad50 elementor-widget elementor-widget-heading\" data-id=\"3e39ad50\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Ihre Experten f\u00fcr diagnostische Studien<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5caf209f elementor-widget elementor-widget-text-editor\" data-id=\"5caf209f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>M\u00f6chten Sie Ihren Assay so schnell wie m\u00f6glich auf den Markt bringen? Wir unterst\u00fctzen Sie dabei \u2013 mit unserer langj\u00e4hrigen Erfahrung in der Validierung diagnostischer Assays, umfassender regulatorischer Expertise, einem umfangreichen Bestand an hausinternen Biomaterialien sowie unseren eigenen Spendezentren.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-55d5ff72 elementor-section-content-middle elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"55d5ff72\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-68753c07\" data-id=\"68753c07\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-555fc49 elementor-align-right elementor-widget__width-auto animated-slow elementor-invisible elementor-widget elementor-widget-button\" data-id=\"555fc49\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;pulse&quot;}\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"mailto:sales@biomex.de\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Kontaktieren Sie Ihre Experten<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<div class=\"elementor-element elementor-element-7f7bc4af elementor-widget elementor-widget-spacer\" data-id=\"7f7bc4af\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>H\u00e4ufig gestellte Fragen: BIOMEX Performance Evaluation Studies Wir sind Ihre Experten f\u00fcr Performance Evaluation Studies im Bereich der In-vitro-Diagnostik und der Assay-Validierung. Nachfolgend finden Sie Antworten auf h\u00e4ufig gestellte Fragen zu diesen Themen. F\u00fcr weitere Anliegen z\u00f6gern Sie bitte nicht, uns direkt zu kontaktieren.\u00a0 1. Hintergrund und Expertise 1. Wo in Europa hat BIOMEX seinen <a class=\"read-more\" href=\"https:\/\/biomex.de\/de\/diagnostik\/faq-diagnostik\/\">Read More<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"parent":19593,"menu_order":2,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-19528","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>FAQ Diagnostik - BIOMEX<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/biomex.de\/de\/diagnostik\/faq-diagnostik\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FAQ Diagnostik - BIOMEX\" \/>\n<meta property=\"og:description\" content=\"H\u00e4ufig gestellte Fragen: BIOMEX Performance Evaluation Studies Wir sind Ihre Experten f\u00fcr Performance Evaluation Studies im Bereich der In-vitro-Diagnostik und der Assay-Validierung. Nachfolgend finden Sie Antworten auf h\u00e4ufig gestellte Fragen zu diesen Themen. F\u00fcr weitere Anliegen z\u00f6gern Sie bitte nicht, uns direkt zu kontaktieren.\u00a0 1. Hintergrund und Expertise 1. Wo in Europa hat BIOMEX seinen Read More\" \/>\n<meta property=\"og:url\" content=\"https:\/\/biomex.de\/de\/diagnostik\/faq-diagnostik\/\" \/>\n<meta property=\"og:site_name\" content=\"BIOMEX\" \/>\n<meta property=\"article:modified_time\" content=\"2025-10-21T12:26:49+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/biomex.de\/wp-content\/uploads\/grafik-ivds_2024-2.png\" \/>\n\t<meta property=\"og:image:width\" content=\"816\" \/>\n\t<meta property=\"og:image:height\" content=\"417\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Gesch\u00e4tzte Lesezeit\" \/>\n\t<meta name=\"twitter:data1\" content=\"19\u00a0Minuten\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/biomex.de\\\/de\\\/diagnostik\\\/faq-diagnostik\\\/\",\"url\":\"https:\\\/\\\/biomex.de\\\/de\\\/diagnostik\\\/faq-diagnostik\\\/\",\"name\":\"FAQ Diagnostik - BIOMEX\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/biomex.de\\\/de\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/biomex.de\\\/de\\\/diagnostik\\\/faq-diagnostik\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/biomex.de\\\/de\\\/diagnostik\\\/faq-diagnostik\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/biomex.de\\\/wp-content\\\/uploads\\\/grafik-ivds_2024-2.png\",\"datePublished\":\"2023-10-19T10:22:24+00:00\",\"dateModified\":\"2025-10-21T12:26:49+00:00\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/biomex.de\\\/de\\\/diagnostik\\\/faq-diagnostik\\\/#breadcrumb\"},\"inLanguage\":\"de\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/biomex.de\\\/de\\\/diagnostik\\\/faq-diagnostik\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"de\",\"@id\":\"https:\\\/\\\/biomex.de\\\/de\\\/diagnostik\\\/faq-diagnostik\\\/#primaryimage\",\"url\":\"https:\\\/\\\/biomex.de\\\/wp-content\\\/uploads\\\/grafik-ivds_2024-2.png\",\"contentUrl\":\"https:\\\/\\\/biomex.de\\\/wp-content\\\/uploads\\\/grafik-ivds_2024-2.png\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/biomex.de\\\/de\\\/diagnostik\\\/faq-diagnostik\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/biomex.de\\\/de\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Diagnostik\",\"item\":\"https:\\\/\\\/biomex.de\\\/de\\\/diagnostics\\\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"FAQ Diagnostik\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/biomex.de\\\/de\\\/#website\",\"url\":\"https:\\\/\\\/biomex.de\\\/de\\\/\",\"name\":\"BIOMEX\",\"description\":\"EMPOWERING EXPERTS\",\"publisher\":{\"@id\":\"https:\\\/\\\/biomex.de\\\/de\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/biomex.de\\\/de\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"de\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/biomex.de\\\/de\\\/#organization\",\"name\":\"BIOMEX\",\"url\":\"https:\\\/\\\/biomex.de\\\/de\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"de\",\"@id\":\"https:\\\/\\\/biomex.de\\\/de\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/biomex.de\\\/wp-content\\\/uploads\\\/2022\\\/11\\\/biomex_logo.svg\",\"contentUrl\":\"https:\\\/\\\/biomex.de\\\/wp-content\\\/uploads\\\/2022\\\/11\\\/biomex_logo.svg\",\"width\":334,\"height\":60,\"caption\":\"BIOMEX\"},\"image\":{\"@id\":\"https:\\\/\\\/biomex.de\\\/de\\\/#\\\/schema\\\/logo\\\/image\\\/\"}}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"FAQ Diagnostik - BIOMEX","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/biomex.de\/de\/diagnostik\/faq-diagnostik\/","og_locale":"de_DE","og_type":"article","og_title":"FAQ Diagnostik - BIOMEX","og_description":"H\u00e4ufig gestellte Fragen: BIOMEX Performance Evaluation Studies Wir sind Ihre Experten f\u00fcr Performance Evaluation Studies im Bereich der In-vitro-Diagnostik und der Assay-Validierung. Nachfolgend finden Sie Antworten auf h\u00e4ufig gestellte Fragen zu diesen Themen. F\u00fcr weitere Anliegen z\u00f6gern Sie bitte nicht, uns direkt zu kontaktieren.\u00a0 1. Hintergrund und Expertise 1. Wo in Europa hat BIOMEX seinen Read More","og_url":"https:\/\/biomex.de\/de\/diagnostik\/faq-diagnostik\/","og_site_name":"BIOMEX","article_modified_time":"2025-10-21T12:26:49+00:00","og_image":[{"width":816,"height":417,"url":"https:\/\/biomex.de\/wp-content\/uploads\/grafik-ivds_2024-2.png","type":"image\/png"}],"twitter_card":"summary_large_image","twitter_misc":{"Gesch\u00e4tzte Lesezeit":"19\u00a0Minuten"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/biomex.de\/de\/diagnostik\/faq-diagnostik\/","url":"https:\/\/biomex.de\/de\/diagnostik\/faq-diagnostik\/","name":"FAQ Diagnostik - BIOMEX","isPartOf":{"@id":"https:\/\/biomex.de\/de\/#website"},"primaryImageOfPage":{"@id":"https:\/\/biomex.de\/de\/diagnostik\/faq-diagnostik\/#primaryimage"},"image":{"@id":"https:\/\/biomex.de\/de\/diagnostik\/faq-diagnostik\/#primaryimage"},"thumbnailUrl":"https:\/\/biomex.de\/wp-content\/uploads\/grafik-ivds_2024-2.png","datePublished":"2023-10-19T10:22:24+00:00","dateModified":"2025-10-21T12:26:49+00:00","breadcrumb":{"@id":"https:\/\/biomex.de\/de\/diagnostik\/faq-diagnostik\/#breadcrumb"},"inLanguage":"de","potentialAction":[{"@type":"ReadAction","target":["https:\/\/biomex.de\/de\/diagnostik\/faq-diagnostik\/"]}]},{"@type":"ImageObject","inLanguage":"de","@id":"https:\/\/biomex.de\/de\/diagnostik\/faq-diagnostik\/#primaryimage","url":"https:\/\/biomex.de\/wp-content\/uploads\/grafik-ivds_2024-2.png","contentUrl":"https:\/\/biomex.de\/wp-content\/uploads\/grafik-ivds_2024-2.png"},{"@type":"BreadcrumbList","@id":"https:\/\/biomex.de\/de\/diagnostik\/faq-diagnostik\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/biomex.de\/de\/"},{"@type":"ListItem","position":2,"name":"Diagnostik","item":"https:\/\/biomex.de\/de\/diagnostics\/"},{"@type":"ListItem","position":3,"name":"FAQ Diagnostik"}]},{"@type":"WebSite","@id":"https:\/\/biomex.de\/de\/#website","url":"https:\/\/biomex.de\/de\/","name":"BIOMEX","description":"EMPOWERING EXPERTS","publisher":{"@id":"https:\/\/biomex.de\/de\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/biomex.de\/de\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"de"},{"@type":"Organization","@id":"https:\/\/biomex.de\/de\/#organization","name":"BIOMEX","url":"https:\/\/biomex.de\/de\/","logo":{"@type":"ImageObject","inLanguage":"de","@id":"https:\/\/biomex.de\/de\/#\/schema\/logo\/image\/","url":"https:\/\/biomex.de\/wp-content\/uploads\/2022\/11\/biomex_logo.svg","contentUrl":"https:\/\/biomex.de\/wp-content\/uploads\/2022\/11\/biomex_logo.svg","width":334,"height":60,"caption":"BIOMEX"},"image":{"@id":"https:\/\/biomex.de\/de\/#\/schema\/logo\/image\/"}}]}},"_links":{"self":[{"href":"https:\/\/biomex.de\/de\/wp-json\/wp\/v2\/pages\/19528","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/biomex.de\/de\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/biomex.de\/de\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/biomex.de\/de\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/biomex.de\/de\/wp-json\/wp\/v2\/comments?post=19528"}],"version-history":[{"count":5,"href":"https:\/\/biomex.de\/de\/wp-json\/wp\/v2\/pages\/19528\/revisions"}],"predecessor-version":[{"id":19785,"href":"https:\/\/biomex.de\/de\/wp-json\/wp\/v2\/pages\/19528\/revisions\/19785"}],"up":[{"embeddable":true,"href":"https:\/\/biomex.de\/de\/wp-json\/wp\/v2\/pages\/19593"}],"wp:attachment":[{"href":"https:\/\/biomex.de\/de\/wp-json\/wp\/v2\/media?parent=19528"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}