{"id":646,"date":"2025-07-29T14:17:18","date_gmt":"2025-07-29T14:17:18","guid":{"rendered":"http:\/\/mdx.local\/?post_type=sector&#038;p=646"},"modified":"2026-04-06T17:14:40","modified_gmt":"2026-04-06T17:14:40","slug":"ivd-end-to-end","status":"publish","type":"sector","link":"https:\/\/mdxcro.com\/fr\/sectors\/ivd-end-to-end\/","title":{"rendered":"IVD End-to-End Services"},"content":{"rendered":"\n<section id=\"block_f36904b4bbdbdbc214b373abef4d56b6\" class=\"hero\">\n    <div class=\"hero--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2026\/04\/sectors-MDx-CRO.webp\" fetchpriority=\"high\" class=\"no-lazy\" \/>\n    <\/div>\n        <div class=\"container\">\n                <div class=\"content\">\n                                    <h1 class=\"title\">End-to-End IVD CRO Services for IVDR &#038; FDA<\/h1>\n            \n                            <div class=\"description\"><p><span style=\"font-weight: 400;\">From regulatory strategy and assay development to clinical validation, CE marking, and post-market support, MDx CRO is your IVD CRO partner across the full lifecycle.<\/span><\/p>\n<\/div>\n            \n                            <div class=\"button-wrapper\">\n                                            <a href=\"https:\/\/mdxcro.com\/contact\/?utm_source=ind_end_to_end\" class=\"button button--default\" target=\"_blank\">\n                            Let\u2019s Talk                        <\/a>\n                                            <a href=\"#process\" class=\"button button--secondary\" target=\"_self\">\n                            Explore Our Process                        <\/a>\n                                    <\/div>\n                            <\/div>\n            <\/div>\n<\/section>\n\n\n\n<section id=\"block_e8a585fec8065b6aaa01210ed4cf2dfb\" class=\"text-image\" style=\"margin-top: var(--wp--preset--spacing--medium); margin-bottom: var(--wp--preset--spacing--medium); \">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">End-to-End IVD CRO Expertise for Market Success<\/h2><div class=\"description wysiwyg\"><p><span style=\"font-weight: 400\">We guide IVD manufacturers through every phase, from concept and product development to IVDR and FDA compliance, clinical validation, and post-market monitoring. Whether you\u2019re launching a new assay, IVD instrument or updating technical documentation, our <strong>IVD CRO ensures compliance, speed, and global market readiness<\/strong>.<\/span><\/p>\n<p>Our teams integrate regulatory, analytical, clinical, and biostatistics expertise under ISO 20916 to de-risk programs and accelerate approvals.<\/p>\n<\/div><\/div><\/div>                            <div class=\"column column--image\"><img decoding=\"async\" class=\"image\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/68778a52ad1ece5602fe45605fa28d420d1bd9a1.jpg\" alt=\"Advanced medical researchers conducting laboratory experiments to accelerate medical technology development for healthcare innovation.\"  \/><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n\n\n<section id=\"block_045e66e8dc07229665e3cd8f735ff4a8\" class=\"tabs\" style=\"padding-top: var(--wp--preset--spacing--regular);\">\n        <div class=\"container\">\n                    <div class=\"title\">IVD CRO Services: Analytical, Clinical &amp; Regulatory<\/div>\n            <\/div>\n\n    <div class=\"tabs-wrapper\">\n        <!-- Tab Navigation -->\n        <div class=\"tab-navigation\">\n                            <button class=\"tab-button active\" data-tab=\"ra-technical-documentation\">\n                    RA &amp; Technical Documentation                <\/button>\n                            <button class=\"tab-button\" data-tab=\"ivd-analytical-studies\">\n                    IVD Analytical Studies                 <\/button>\n                            <button class=\"tab-button\" data-tab=\"ivd-clinical-studies\">\n                    IVD Clinical Studies                <\/button>\n                            <button class=\"tab-button\" data-tab=\"usability-engineering-human-factors\">\n                    Usability Engineering &amp; Human Factors                <\/button>\n                            <button class=\"tab-button\" data-tab=\"representative-services\">\n                    Representative Services                <\/button>\n                    <\/div>\n\n        <!-- Tab Content -->\n        <div class=\"tab-content-wrapper\">\n                            <div class=\"tab-content active\" id=\"ra-technical-documentation\">\n                    <div class=\"tab-grid\">\n                        <div class=\"tab-left\">\n                            <h3>RA &amp; Technical Documentation<\/h3>\n                            <div class=\"description wysiwyg\">\n                                <p><a href=\"https:\/\/mdxcro.com\/fr\/services\/regulatory-affairs-technical-documentation\/\"><strong>Comprehensive support from strategy to submission and post-market compliance<\/strong><\/a><\/p>\n<p>\u2022 Regulatory Strategy &amp; Market Pathway Definition<br \/>\n\u2022 IVD Classification, GSPRs &amp; ISO 14971 Risk Management<br \/>\n\u2022 CE Marking &amp; Notified Body Engagement<br \/>\n\u2022 510(k), PMA &amp; Global Regulatory Submissions<br \/>\n\u2022 EUDAMED Registration &amp; UDI Consulting<br \/>\n\u2022 Design History Files (DHF) &amp; Technical Documentation<br \/>\n\u2022 Performance Evaluation Plans (PEP) &amp; Reports (PER)<br \/>\n\u2022 Clinical Evidence &amp; Scientific Validity Reports (SVRs)<br \/>\n\u2022 Summary of Safety &amp; Performance (SSP)<br \/>\n\u2022 Labelling &amp; IFU Development<br \/>\n\u2022 Post-Market Surveillance (PMS, PMPF, PSURs)<\/p>\n                            <\/div>\n                        <\/div>\n                        <div class=\"tab-right\">\n                                                            <div class=\"tab-image\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/results.jpg\" alt=\"Cutting-edge MedTech innovation laboratory with diverse scientists collaborating on medical device development.\" \/>\n                                <\/div>\n                                                    <\/div>\n                    <\/div>\n                    <div class=\"tab-navigation-buttons\">\n                        <button class=\"nav-button prev-button\">Previous<\/button>\n                        <button class=\"nav-button next-button\">\n                            Continue to RA &#038; Technical Documentation                        <\/button>\n                    <\/div>\n                <\/div>\n                            <div class=\"tab-content\" id=\"ivd-analytical-studies\">\n                    <div class=\"tab-grid\">\n                        <div class=\"tab-left\">\n                            <h3>IVD Analytical Studies <\/h3>\n                            <div class=\"description wysiwyg\">\n                                <p><a href=\"https:\/\/mdxcro.com\/fr\/services\/ivd-analytical-studies\/\"><strong>End-to-end support for assay design, verification, and analytical validation<\/strong><\/a><\/p>\n<p>\u2022 Analytical Validation Planning<br \/>\n\u2022 IVD Product Development &amp; Assay Validation\u2022 Biomarker &amp; Molecular Assay Development (PCR, LFA, NGS)<br \/>\n\u2022 Analytical Performance Reports (APR)<br \/>\n\u2022 CLSI Compliance<br \/>\n\u2022 Stability Studies<\/p>\n                            <\/div>\n                        <\/div>\n                        <div class=\"tab-right\">\n                                                            <div class=\"tab-image\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/scientific-validity-scaled.jpeg\" alt=\"Advanced medical data analysis using digital dashboards in a modern laboratory environment.\" \/>\n                                <\/div>\n                                                    <\/div>\n                    <\/div>\n                    <div class=\"tab-navigation-buttons\">\n                        <button class=\"nav-button prev-button\">Previous<\/button>\n                        <button class=\"nav-button next-button\">\n                            Continue to IVD Analytical Studies                         <\/button>\n                    <\/div>\n                <\/div>\n                            <div class=\"tab-content\" id=\"ivd-clinical-studies\">\n                    <div class=\"tab-grid\">\n                        <div class=\"tab-left\">\n                            <h3>IVD Clinical Studies<\/h3>\n                            <div class=\"description wysiwyg\">\n                                <p><a href=\"https:\/\/mdxcro.com\/fr\/services\/ivd-clinical-studies\/\"><strong>Full-service support for clinical performance evaluation<\/strong><\/a><\/p>\n<p>\u2022 Study &amp; Protocol Design<br \/>\n\u2022 Clinical Performance Studies &amp; Site Management<br \/>\n\u2022 IVD Study Monitoring<br \/>\n\u2022 Biostatistics &amp; Data Management<br \/>\n\u2022 eCRF &amp; eTMF Design<br \/>\n\u2022 ISO 20916 Compliance<\/p>\n                            <\/div>\n                        <\/div>\n                        <div class=\"tab-right\">\n                                                            <div class=\"tab-image\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/clinical-development.jpg\" alt=\"Advanced medical research laboratory with scientists using microscopes to develop innovative MedTech solutions for healthcare.\" \/>\n                                <\/div>\n                                                    <\/div>\n                    <\/div>\n                    <div class=\"tab-navigation-buttons\">\n                        <button class=\"nav-button prev-button\">Previous<\/button>\n                        <button class=\"nav-button next-button\">\n                            Continue to IVD Clinical Studies                        <\/button>\n                    <\/div>\n                <\/div>\n                            <div class=\"tab-content\" id=\"usability-engineering-human-factors\">\n                    <div class=\"tab-grid\">\n                        <div class=\"tab-left\">\n                            <h3>Usability Engineering &amp; Human Factors<\/h3>\n                            <div class=\"description wysiwyg\">\n                                <p><a href=\"https:\/\/mdxcro.com\/fr\/services\/usability-engineering\/\"><strong>Designing for user safety and compliance across all IVD formats<\/strong><\/a><\/p>\n<p>\u2022 IEC 62366 Compliance<br \/>\n\u2022 Formative &amp; Summative Usability Testing<br \/>\n\u2022 Usability Protocols &amp; Label Comprehension Studies<br \/>\n\u2022 Usability Studies for Point-of-Care IVDs<br \/>\n\u2022 Participant Recruitment<\/p>\n                            <\/div>\n                        <\/div>\n                        <div class=\"tab-right\">\n                                                            <div class=\"tab-image\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/regulatory-excelence.jpg\" alt=\"Advanced healthcare professionals discussing innovative MedTech solutions on a tablet in a modern clinical setting.\" \/>\n                                <\/div>\n                                                    <\/div>\n                    <\/div>\n                    <div class=\"tab-navigation-buttons\">\n                        <button class=\"nav-button prev-button\">Previous<\/button>\n                        <button class=\"nav-button next-button\">\n                            Continue to Usability Engineering &#038; Human Factors                        <\/button>\n                    <\/div>\n                <\/div>\n                            <div class=\"tab-content\" id=\"representative-services\">\n                    <div class=\"tab-grid\">\n                        <div class=\"tab-left\">\n                            <h3>Representative Services<\/h3>\n                            <div class=\"description wysiwyg\">\n                                <p><a href=\"https:\/\/mdxcro.com\/fr\/services\/representative-services\/\"><strong>EU &amp; UK market access through local representation<\/strong><\/a><\/p>\n<p>\u2022 EU Authorised Representative (EC Rep)<br \/>\n\u2022 UK Responsible Person (UK RP)<br \/>\n\u2022 Interface with Authorities &amp; Notified Bodies<br \/>\n\u2022 Labeling &amp; Vigilance Support<\/p>\n                            <\/div>\n                        <\/div>\n                        <div class=\"tab-right\">\n                                                            <div class=\"tab-image\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/design-sponsor.jpg\" alt=\"Innovative MedTech team celebrating success at a corporate meeting, emphasizing collaboration and innovation in healthcare technology.\" \/>\n                                <\/div>\n                                                    <\/div>\n                    <\/div>\n                    <div class=\"tab-navigation-buttons\">\n                        <button class=\"nav-button prev-button\">Previous<\/button>\n                        <button class=\"nav-button next-button\">\n                            Continue to Representative Services                        <\/button>\n                    <\/div>\n                <\/div>\n                    <\/div>\n    <\/div>\n<\/section>\n\n\n\n<section id=\"process\" class=\"flip-cards flip-cards--three-columns flip-cards--grayscale flip-cards--card-size-small \" style=\"\">\n            <div class=\"container\">\n        <div class=\"content\">\n            \n                            <h2 class=\"title\">Our IVD CRO: From Concept to Market<\/h2>\n            \n            \n                    <\/div>\n\n                    <div class=\"grid\">\n                                    <div class=\"card card--background-blue\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Regulatory Strategy<\/div>\n                        <div class=\"back\"><p>Define regulatory pathway, device classification, and regional market strategy.<\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--has-bg-image\"\n                         style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/assay-software-development.jpg&#039;);\"                         >\n                        \n                                                                            \n                        <div class=\"front\">Assay or Software Development<\/div>\n                        <div class=\"back\"><p>Design and validate your assay, software, or IVD product for analytical and functional performance.<\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-white\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Clinical Validation<\/div>\n                        <div class=\"back\"><p>Plan and execute clinical performance studies in alignment with ISO 20916, IVDR and FDA requirements.<\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--has-bg-image\"\n                         style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/technical-doc.jpg&#039;);\"                         >\n                        \n                                                                            \n                        <div class=\"front\">Technical Documentation<\/div>\n                        <div class=\"back\"><p>Compile IVDR technical documentation or FDA design history file, including labeling and risk analysis.<\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-black\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Regulatory Submission<\/div>\n                        <div class=\"back\"><p>Prepare and submit dossiers for CE marking, 510(k), or PMA, and support notified body or FDA interactions.<\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--has-bg-image\"\n                         style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/post-market.jpg&#039;);\"                         >\n                        \n                                                                            \n                        <div class=\"front\">Post-Market Support<\/div>\n                        <div class=\"back\"><p>Maintain compliance through PMS, PSURs, PMPF studies, and EUDAMED\/UDI reporting.<\/p>\n<\/div>\n                    <\/div>\n                            <\/div>\n        \n            <\/div>\n<\/section>\n\n\n<section id=\"block_6e6e12e2c90a0f2f20de7a6f331bb9a4\" class=\"content-columns content-columns--three-columns content-columns--background-white\" style=\"\">\n        <div class=\"container\">\n                    <div class=\"content\">\n                                    <h2 class=\"title\">Our IVD Expertise<\/h2>\n                                                    <div class=\"description wysiwyg\">\n                        <p>As a specialized IVD CRO, we support multiple scientific areas, applications, and technologies.<\/p>\n                    <\/div>\n                            <\/div>\n        \n                    <div class=\"grid\">\n                                                        <div class=\"card card--background-blue\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Scientific Areas<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li>Precision Medicine &amp; Companion diagnostics<\/li>\n<li>Genetic Testing<\/li>\n<li>Cancer Screening<\/li>\n<li>Infectious Diseases<\/li>\n<li>Physiological Markers<\/li>\n<li>Hematology &amp; Hemostasis<\/li>\n<li>Transfusion Medicine<\/li>\n<li>Biochemistry, Microbiology &amp; more<\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-blue\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Applications<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li>Professional Use<\/li>\n<li>Point of Care<\/li>\n<li>Self-Tests<\/li>\n<li>IVD Software<\/li>\n<li>Laboratory Developed Tests (US)<\/li>\n<li>In-house Assays (EU)<\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-black\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Technologies<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li>NGS<\/li>\n<li>Molecular<\/li>\n<li>Immunoassays<\/li>\n<li>Immunohistochemistry<\/li>\n<li>Multiplex<\/li>\n<li>Lateral Flow<\/li>\n<li>Microfluidic &amp; more<\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                <\/div>\n                  \n          \n\n            <\/div>\n<\/section>\n\n\n\n<section id=\"block_95eedd4621117354920b01cac4945c9c\" class=\"case-study-quote\" style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/testimonials-bg.jpg&#039;);\">\n    \n        <div class=\"case-study-quote--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/testimonials-bg.jpg\" \/>\n    <\/div>\n    <div class=\"container\">\n                    <div class=\"headline\">Why Diagnostics Teams Choose MDx as Their IVD CRO?<\/div>\n        \n                    <div class=\"slider\">\n                                    <div class=\"slider-item\" data-button-url=\"https:\/\/mdxcro.com\/fr\/case-studies\/clia-cap-genetic-testing-laboratory\/\">\n\n                                                    <div class=\"box-grid\">\n                                                                    <div class=\"box\">\n                                                                                    <div class=\"value\">100% <\/div>\n                                                                                                                            <div class=\"legend\">CE marking success rate<\/div>\n                                                                            <\/div>\n                                                                    <div class=\"box\">\n                                                                                    <div class=\"value\">9.4\/10 <\/div>\n                                                                                                                            <div class=\"legend\">Client satisfaction<\/div>\n                                                                            <\/div>\n                                                                    <div class=\"box\">\n                                                                                    <div class=\"value\"> 85% <\/div>\n                                                                                                                            <div class=\"legend\">Repeat business rate<\/div>\n                                                                            <\/div>\n                                                                    <div class=\"box\">\n                                                                                    <div class=\"value\">Trusted by 4 <\/div>\n                                                                                                                            <div class=\"legend\">of the world\u2019s top 10 IVD manufacturers<\/div>\n                                                                            <\/div>\n                                                            <\/div>\n                                                \n                                                    <p class=\"quote\">\u00ab\u00a0We partnered with MDx to navigate the complexities of IVDR compliance and secure CE marking for our NGS-based panel. Their deep regulatory expertise, particularly in designing technical documentation and their understanding of Notified Body expectations, proved indispensable. Within 16 months, we had not only achieved CE marking but accelerated our European market entry by over 40%. MDx didn\u2019t just support our compliance\u2014they propelled our success.\u00a0\u00bb<\/p>\n                                                                            <p class=\"author\">\n                                Senior VP, Regulatory Affairs                                                                 <br>Major U.S.-based Genetic Testing Laboratory                                                            <\/p>\n                                            <\/div>\n                            <\/div>\n        \n        <div class=\"footer\">\n            <div class=\"slider-dots\"><\/div>\n            <div class=\"button-wrapper\">\n                <a href=\"\/resources\/?category=case-studies\" class=\"button button--tertiary\">View Case Studies<\/a>\n            <\/div>\n        <\/div>\n    <\/div>\n<\/section>\n\n\n\n<section id=\"block_5c9385c87a80c30320e97a71b9163591\" class=\"content-columns content-columns--three-columns content-columns--background-white\" style=\"\">\n        <div class=\"container\">\n                    <div class=\"content\">\n                                    <h2 class=\"title\">Who We <span class=\"blue-highlight\"> Support <\/span> as an IVD CRO<\/h2>\n                                            <\/div>\n        \n                    <div class=\"grid\">\n                                                        <div class=\"card card--background-white-frost\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Early-stage diagnostic innovators &#038; start-ups<\/h3>\n                                                                                <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white-frost\">\n                                            <div class=\"top\">\n                                                          <div class=\"circle\">\n                                                                <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/text-image-icon.svg\" alt=\"\">\n                                                                                          <\/div>\n                                                                                        <h3 class=\"headline\">Global IVD manufacturers<\/h3>\n                                                                                <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white-frost\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Precision Medicine companies<\/h3>\n                                                                                <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white-frost\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Digital health &#038; AI companies<\/h3>\n                                                                                <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white-frost\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">US companies seeking \u2028EU IVDR access<\/h3>\n                                                                                <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white-frost\">\n                                            <div class=\"top\">\n                                                          <div class=\"circle\">\n                                                                <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX-Icon-Black-11.svg\" alt=\"\">\n                                                                                          <\/div>\n                                                                                        <h3 class=\"headline\">Pharma &#038; Biotech companies developing CDx<\/h3>\n                                                                                <\/div>\n                                                                    <\/div>\n                                                <\/div>\n                  \n          \n\n            <\/div>\n<\/section>\n\n\n\n<section id=\"block_dc962b30c09404cf8976c81f33c991a8\" class=\"case-study-details\" style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/software-ivd.jpg&#039;);\">\n    \n    \n    <div class=\"container\">\n        \n                    <div class=\"slider\">\n                                    <div class=\"slider-item\" data-button-url=\"https:\/\/mdxcro.com\/fr\/case-studies\/clia-cap-genetic-testing-laboratory\/\">\n                                                <div class=\"subtitle\">CLIA\/CAP Genetic Testing Laboratory<\/div>\n                                            <div class=\"list\">\n                                                    <div class=\"list-item\">\n                                                                <div class=\"icon\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/challenge.svg\" alt=\"Challenge\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\"> Challenge <\/span>\n                                        <p>LDT to IVDR transition + CE mark for an NGS Clinical Exome Sequencing (CES) panel targeting over 4000 genes<\/p>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                                                    <div class=\"list-item\">\n                                                                <div class=\"icon\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/solution.svg\" alt=\"Solution\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\"> Solution <\/span>\n                                        <p>Full technical documentation development for NGS, bioinformatics pipeline, 13485 QMS implementation and notified body submission<\/p>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                                                    <div class=\"list-item\">\n                                                                <div class=\"icon\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/result.svg\" alt=\"Result\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\"> Result <\/span>\n                                        <p>CE mark granted in 16 months, enabling the client to become one of the very few laboratories globally to certify such a comprehensive gene panel under IVDR<\/p>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                                                <\/div>\n                    <\/div>\n                            <\/div>\n        \n        <div class=\"footer\">\n            <div class=\"slider-dots\"><\/div>\n            <div class=\"button-wrapper\">\n                <a href=\"\/resources\/?category=case-studies\" class=\"button button--tertiary\">View Case Studies<\/a>\n            <\/div>\n        <\/div>\n    <\/div>\n<\/section>\n\n\n<section id=\"block_63f7b03f44ab012d8950d0642a094816\" class=\"faqs\" style=\"\">\n    <div class=\"container\">\n    <div class=\"content\">\n      <div class=\"column\">\n                  <h2 class=\"headline\">Frequently Asked Questions<\/h2>\n                          <a class=\"button button--quaternary\" href=\"https:\/\/mdxcro.com\/contact\/\" target=\"\">\n            Ask Us a Question          <\/a>\n              <\/div>\n      <div class=\"column\">\n                  <ul class=\"faq-list\">\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">How does an IVD CRO run ISO 20916 clinical performance studies?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p>We scope endpoints and study design, develop protocols and eCRFs, qualify sites, monitor conduct, manage data and biostatistics, and compile clinical evidence for the performance evaluation report. Our approach aligns with IVDR Annex XIII\/XIV and Notified Body expectations.<\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">What does an IVD CRO do?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><strong>An IVD CRO designs and executes analytical and clinical performance activities, prepares technical documentation, and supports IVDR and FDA submissions.<\/strong> At MDx CRO, we integrate regulatory, biostatistics, site management, and quality to deliver ISO 20916-compliant evidence for CE marking and U.S. approvals.<\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Are clinical studies required for EU IVDR compliance?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Not always. Under EU IVDR, clinical performance must be demonstrated through one or more of the following sources:<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400\">Clinical performance studies (Annex XIII &amp; Annex XIV),<\/span><\/li>\n<\/ul>\n<ul>\n<li><span style=\"font-weight: 400\">Scientific literature relevant to the device\u2019s intended purpose, or<\/span><\/li>\n<\/ul>\n<ul>\n<li><span style=\"font-weight: 400\">Published experience from routine diagnostic use.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400\">Manufacturers must plan this evidence in the Performance Evaluation Plan (PEP) and summarize it in the Clinical Performance Report (CPR) and Performance Evaluation Report (PER). While not all IVDs require a new clinical study, <\/span><i><span style=\"font-weight: 400\">at least one of these sources<\/span><\/i><span style=\"font-weight: 400\"> must be available and sufficient to support the claimed clinical performance.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Can MDx support LDT-to-IVD transitions?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Yes, we help labs and test developers convert LDTs into compliant IVDs with support on documentation, validation, and market pathway selection.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">How long does CE marking typically take?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Most clients reach CE mark readiness within 6\u201318 months depending on risk class, data readiness, and notified body availability.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                      <\/ul>\n              <\/div>\n    <\/div>\n  <\/div>\n<\/section>\n\n  <script type=\"application\/ld+json\">\n    {\"@context\":\"https:\/\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"How does an IVD CRO run ISO 20916 clinical performance studies?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"We scope endpoints and study design, develop protocols and eCRFs, qualify sites, monitor conduct, manage data and biostatistics, and compile clinical evidence for the performance evaluation report. 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