{"id":12057,"date":"2025-09-18T16:34:17","date_gmt":"2025-09-18T16:34:17","guid":{"rendered":"https:\/\/mdxcro.com\/services\/etudes-cliniques-sur-les-dispositifs-medicaux-de-diagnostic-in-vitro\/"},"modified":"2026-07-22T10:07:48","modified_gmt":"2026-07-22T10:07:48","slug":"etudes-cliniques-dispositifs-diagnostic-in-vitro","status":"publish","type":"service","link":"https:\/\/mdxcro.com\/fr\/services\/etudes-cliniques-dispositifs-diagnostic-in-vitro\/","title":{"rendered":"\u00c9tudes cliniques IVD"},"content":{"rendered":"\n<section id=\"block_23b9efdcb6bacc5e141c9dd764e490d3\" 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\" alt=\"\" \/>\n    <\/div>\n        <div class=\"container\">\n                <div class=\"content\">\n                                    <h1 class=\"title\">\u00c9tudes de performance clinique des DIV : services de CRO de bout en bout pour l\u2019IVDR, la FDA et les march\u00e9s mondiaux<\/h1>\n            \n                            <div class=\"description\"><p>MDx est une CRO (organisme de recherche sous contrat) sp\u00e9cialis\u00e9e dans les DIV, proposant des \u00e9valuations de performance clinique dirig\u00e9es par des experts pour l\u2019IVDR, la FDA et les march\u00e9s mondiaux. Nos services d\u2019\u00e9tudes cliniques pour DIV incluent le d\u00e9veloppement complet de protocoles, la gestion de sites, les soumissions aux comit\u00e9s d\u2019\u00e9thique et la documentation r\u00e9glementaire.<br \/>\n<strong>Plus de 40 programmes de DIV combin\u00e9s<\/strong><!-- notionvc: f2b88958-b597-48c8-a9f2-dc38812610be --><\/p>\n<\/div>\n            \n                            <div class=\"button-wrapper\">\n                                            <a href=\"https:\/\/mdxcro.com\/fr\/contact\/?utm_source=ivd_clinical_studies\" class=\"button bouton--par d\u00e9faut\" target=\"_self\">\n                            R\u00e9server un appel de d\u00e9couverte                        <\/a>\n                                            <a href=\"https:\/\/mdxcro.com\/running-clinical-studies-under-ivdr-what-you-need-to-know\/\" class=\"button bouton--secondaire\" target=\"_self\">\n                            Lire notre guide sur les \u00e9tudes cliniques                        <\/a>\n                                    <\/div>\n                            <\/div>\n            <\/div>\n<\/section>\n\n<section id=\"block_08dfe6e87e6e945a98a0153cd88922b5\" class=\"text-image text-image--video-player\" style=\"\">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">Pourquoi les \u00e9tudes cliniques pour DIV sont essentielles<\/h2><div class=\"description wysiwyg\"><p><span style=\"font-weight: 400\"><strong>La r\u00e9ussite des \u00e9tudes de performance clinique des DIV est cruciale pour l\u2019<span class=\"blue-highlight\"> acc\u00e8s au march\u00e9 <\/span> dans le cadre de l\u2019IVDR, de la FDA et des cadres r\u00e9glementaires mondiaux.<\/strong> <\/span><\/p>\n<p><span style=\"font-weight: 400\">Que vous d\u00e9veloppiez un essai de classe D \u00e0 haut risque, un diagnostic compagnon <strong><span class=\"blue-highlight\"> (CDx) <\/span><\/strong> ou que vous passiez de la DIVD \u00e0 l\u2019IVDR, MDx CRO garantit que vos preuves cliniques r\u00e9pondent aux attentes r\u00e9glementaires gr\u00e2ce \u00e0 une \u00e9valuation rigoureuse des performances cliniques et \u00e0 une conception d\u2019\u00e9tude strat\u00e9gique.<\/span><\/p>\n<p><span style=\"font-weight: 400\">Notre \u00e9quipe fournit des <strong><span class=\"blue-highlight\"> solutions d\u2019\u00e9tudes cliniques de bout en bout <\/span><\/strong> \u2014 des soumissions selon les Annexes XIII\/XIV de l\u2019IVDR et des protocoles d\u2019\u00e9tude de performance clinique (CPSP) \u00e0 la gestion de sites, aux approbations des comit\u00e9s d\u2019\u00e9thique et aux rapports finaux de performance clinique. Gr\u00e2ce \u00e0 notre expertise en mati\u00e8re d\u2019ISO 20916 et de conformit\u00e9 \u00e0 l\u2019IVDR, nous veillons \u00e0 ce que votre DIV re\u00e7oive une approbation rapide avec des preuves cliniques solides.  <\/span><\/p>\n<\/div><\/div><\/div>                            <div class=\"column column--image\"><div class=\"video-player video-player--youtube\" data-youtube-url=\"https:\/\/www.youtube.com\/embed\/nKpFU7PGN5U?si=NIs7BU6aOYXYixgu\"><div class=\"youtube-container\"><div class=\"youtube-poster\"><img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/What-is-a-Clinical-Performance-Study-under-IVDR-2.jpg\" alt=\"Innovative MDX MedTech clinical performance study showcasing advancements in medical technology and device efficiency.\" \/><button class=\"play-btn youtube-play-btn\"><\/button><\/div><div class=\"youtube-iframe-container\" style=\"display: none\"><!-- Iframe will be created here dynamically --><\/div><\/div><\/div><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n<section id=\"block_95016377046c2684bd70ec3fb6393c80\" class=\"flip-cards flip-cards--three-columns flip-cards--grayscale \" style=\"padding-top: var(--wp--preset--spacing--regular); padding-bottom: var(--wp--preset--spacing--regular); \">\n            <div class=\"container\">\n        <div class=\"content\">\n            \n                            <h2 class=\"title\">Conception et ex\u00e9cution d\u2019\u00e9tudes cliniques compl\u00e8tes<\/h2>\n            \n                            <div class=\"teaser wysiwyg\"><p>MDx fournit des services de performance clinique pour DIV de bout en bout, g\u00e9rant chaque phase du cycle de vie de votre \u00e9tude :<\/p>\n<\/div>\n            \n                    <\/div>\n\n                    <div class=\"grid\">\n                                    <div class=\"card card--background-white card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">1.<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Planification et strat\u00e9gie<\/div>\n                        <div class=\"back\"><ul>\n<li>Strat\u00e9gie et parcours clinique IVDR<\/li>\n<li>Conception de l\u2019\u00e9tude de performance clinique (CPSP)<\/li>\n<li>Faisabilit\u00e9 et \u00e9valuation des risques de l\u2019\u00e9tude<\/li>\n<li>Planification et calendriers align\u00e9s sur l\u2019ISO 20916<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-blue card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">2.<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Documentation et soumissions<\/div>\n                        <div class=\"back\"><ul>\n<li>D\u00e9veloppement du CPSP<\/li>\n<li>Planification et alignement des preuves selon les Annexes XIII\/XIV<\/li>\n<li>Soumissions et dossiers pour les comit\u00e9s d\u2019\u00e9thique \/ IRB<\/li>\n<li>Documentation et interactions avec les autorit\u00e9s comp\u00e9tentes<\/li>\n<li>Cr\u00e9ation de la brochure de l\u2019investigateur<\/li>\n<li>Notifications d\u2019\u00e9tudes de performance sur EUDAMED<\/li>\n<li>Mise en place et maintenance du TMF<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-black card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">3.<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Gestion de site et ex\u00e9cution<\/div>\n                        <div class=\"back\"><ul>\n<li>S\u00e9lection, qualification et initiation des sites et laboratoires<\/li>\n<li>Formation des investigateurs et visites d\u2019initiation de site<\/li>\n<li>Suivi clinique (sur site et \u00e0 distance) selon l\u2019ISO 20916<\/li>\n<li>Logistique et tra\u00e7abilit\u00e9 des \u00e9chantillons biologiques<\/li>\n<li>Conception, cr\u00e9ation et mise en \u0153uvre de CRF\/eCRF<\/li>\n<li>Surveillance de l\u2019adh\u00e9sion au protocole et r\u00e9solution des probl\u00e8mes<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-black card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">4.<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Gestion des donn\u00e9es et rapports<\/div>\n                        <div class=\"back\"><ul>\n<li>Conception et validation d\u2019eCRF ; saisie des donn\u00e9es et contr\u00f4le qualit\u00e9<\/li>\n<li>D\u00e9veloppement et ex\u00e9cution du plan d\u2019analyse statistique<\/li>\n<li>Rapports de performance clinique ; dossiers finaux de preuves cliniques<\/li>\n<li>Suivi et rapprochement des d\u00e9faillances des dispositifs<\/li>\n<li>V\u00e9rification de l\u2019exhaustivit\u00e9 du TMF et cl\u00f4ture<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-blue card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">5.<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Affaires r\u00e9glementaires, s\u00e9curit\u00e9 et repr\u00e9sentation<\/div>\n                        <div class=\"back\"><ul>\n<li>Surveillance des \u00e9v\u00e9nements ind\u00e9sirables et rapports de s\u00e9curit\u00e9 pour les \u00e9tudes de performance<\/li>\n<li>Communications continues avec les autorit\u00e9s r\u00e9glementaires<\/li>\n<li>Coordination avec les organismes notifi\u00e9s<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-white card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">6.<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Repr\u00e9sentation mondiale<\/div>\n                        <div class=\"back\"><ul>\n<li>Mandataire europ\u00e9en pour les promoteurs hors UE ;<\/li>\n<li>UK RP pour les promoteurs hors Royaume-Uni<\/li>\n<li>Harmonisation des \u00e9tudes multi-pays<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                            <\/div>\n        \n            <\/div>\n<\/section>\n<section id=\"block_29aae47fdf0ec165ee926047e9895dbf\" class=\"text-image\" style=\"padding-bottom: var(--wp--preset--spacing--regular); \">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">Alignement r\u00e9glementaire<\/h2><div class=\"description wysiwyg\"><p><span style=\"font-weight: 400\">MDx garantit que vos \u00e9tudes cliniques pour DIV sont conformes \u00e0 toutes les r\u00e9glementations pertinentes :<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400\"><b>IVDR 2017\/746<\/b><span style=\"font-weight: 400\"> \u2014 Annexe XIII, Annexe XIV, Articles 58, 61-69<\/span><\/li>\n<li style=\"font-weight: 400\"><b>ISO 20916:2024<\/b><span style=\"font-weight: 400\"> \u2014 \u00c9tudes de performance clinique pour les DIV<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Exigences de la FDA<\/b><span style=\"font-weight: 400\"> pour les \u00e9tudes cliniques de DIV<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Principes de l\u2019ISO 14155<\/b><span style=\"font-weight: 400\"> le cas \u00e9ch\u00e9ant<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Principes BPC<\/b><span style=\"font-weight: 400\"> adapt\u00e9s aux \u00e9tudes de performance des DIV<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Exigences des comit\u00e9s d\u2019\u00e9thique<\/b><span style=\"font-weight: 400\"> locaux<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Exigences des autorit\u00e9s comp\u00e9tentes <\/b><span style=\"font-weight: 400\">nationales<\/span><\/li>\n<\/ul>\n<\/div><\/div><\/div>                            <div class=\"column column--image\"><img decoding=\"async\" class=\"image\" 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.\"  \/><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n<section id=\"block_cd57e0a45ba68bab9f70d7303a5b6f92\" class=\"text-image-wrapper\" style=\"padding-bottom: var(--wp--preset--spacing--regular); \">\n    <div class=\"container\">\n                <div class=\"grid-wrapper\">\n            <section class=\"text-image\">\n                <div class=\"container\">\n                    <div class=\"grid\">\n                        <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">\u00c9tudes cliniques pour DIV pour les promoteurs bas\u00e9s aux \u00c9tats-Unis et programmes combin\u00e9s m\u00e9dicament-diagnostic<\/h2><div class=\"description wysiwyg\"><p>De nombreux promoteurs bas\u00e9s aux \u00c9tats-Unis qui entrent en Europe pour la premi\u00e8re fois sont surpris de constater que les obligations du promoteur selon l\u2019IVDR ressemblent peu au cadre de la FDA qu\u2019ils connaissent. De m\u00eame, les d\u00e9veloppeurs europ\u00e9ens de DIV ciblant le march\u00e9 am\u00e9ricain sous-estiment souvent ce qu\u2019il faut pour aligner leur dossier de preuves cliniques sur les exigences PMA ou De Novo de la FDA. <\/p>\n<\/div><\/div><\/div>                        <div class=\"column column--image\"><img decoding=\"async\" class=\"image\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2026\/06\/FDA-IVD-Regulation-MDx-CRO.webp\" alt=\"A needle dispensing medication into a test tube in a laboratory setting, emphasizing precision and sterile techniques for medical research and diagnostics.\"  \/><\/div>                    <\/div>\n                <\/div>\n            <\/section>\n            <section class=\"text-image\">\n                <div class=\"container\">\n                    <div class=\"grid\">\n                        <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">\u00c9tudes cliniques pour DIV pour les promoteurs bas\u00e9s aux \u00c9tats-Unis et programmes combin\u00e9s m\u00e9dicament-diagnostic<\/h2><div class=\"description wysiwyg\"><p>Chez MDx, nous agissons en tant que votre mandataire europ\u00e9en en vertu de l\u2019article 58 de l\u2019IVDR, offrant aux organisations bas\u00e9es aux \u00c9tats-Unis un interlocuteur unique et responsable en Europe. Nous alignons le protocole d\u2019\u00e9tude de performance clinique sur la logique des programmes IND et IDE, afin que les preuves g\u00e9n\u00e9r\u00e9es servent les deux cadres r\u00e9glementaires. Nous g\u00e9rons \u00e9galement la strat\u00e9gie \u00ab Wave 1 \u00bb sp\u00e9cifique \u00e0 chaque pays dans les \u00c9tats membres de l\u2019UE, en adaptant les dossiers de l\u2019Annexe XIV aux exigences de chaque autorit\u00e9 comp\u00e9tente nationale \u2014 des soumissions \u00e9lectroniques via le CTIS aux soumissions papier avec signatures manuscrites.  <\/p>\n<h3>Pour les programmes combin\u00e9s m\u00e9dicament-diagnostic (IND + IVDR)<\/h3>\n<p>Nous poss\u00e9dons une exp\u00e9rience directe sur plus de 40 programmes combin\u00e9s, g\u00e9rant la composante de l\u2019\u00e9tude de performance IVDR en parall\u00e8le avec le calendrier IND du promoteur du m\u00e9dicament. Nous coordonnons le dossier de l\u2019Annexe XIV avec le protocole de l\u2019essai clinique afin que les donn\u00e9es de l\u2019\u00e9tude de performance servent de preuves r\u00e9glementaires valides sous l\u2019IVDR sans dupliquer le travail clinique. Les promoteurs qui traitent la demande d\u2019\u00e9tude de performance comme une r\u00e9flexion apr\u00e8s coup par rapport \u00e0 la demande d\u2019essai clinique perdent g\u00e9n\u00e9ralement 6 \u00e0 12 mois. Nous int\u00e9grons le flux de travail IVDR d\u00e8s le premier jour de la conception de l\u2019essai.<br \/>\nDans le cadre d\u2019un programme avec un partenaire pharmaceutique mondial du top 5, une s\u00e9rie d\u2019\u00e9v\u00e9nements de s\u00e9curit\u00e9 a n\u00e9cessit\u00e9 l\u2019int\u00e9gration urgente de tests g\u00e9n\u00e9tiques dans une \u00e9tude de phase 1 en cours. MDx a \u00e9labor\u00e9 le dossier technique complet de l\u2019Annexe XIV de l\u2019IVDR et a obtenu des approbations multi-pays en six semaines, en partant de z\u00e9ro documentation.    <\/p>\n<\/div><\/div><\/div>                        <div class=\"column column--image\"><\/div>                    <\/div>\n                <\/div>\n            <\/section>\n        <\/div>\n    <\/div>\n<\/section>\n\n<section id=\"block_a56c00e37a2c458fbb25806305e160da\" class=\"content-columns content-columns--four-columns \" style=\"\">\n        <div class=\"container\">\n                    <div class=\"content\">\n                                    <h2 class=\"title\">Types d\u2019\u00e9tudes que nous prenons en charge<\/h2>\n                                            <\/div>\n        \n                    <div class=\"grid\">\n                                                        <div class=\"card card--background-white\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">\u00c9tudes de performance clinique<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><p><span style=\"font-weight: 400\">Sensibilit\u00e9 diagnostique, sp\u00e9cificit\u00e9, VPP, VPN, PPA, NPA, utilit\u00e9 clinique<\/span><\/p>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-black\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Litt\u00e9rature scientifique (\u00e9valu\u00e9e par les pairs)<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><p><span style=\"font-weight: 400\">G\u00e9n\u00e9ration de preuves bas\u00e9es sur la litt\u00e9rature<\/span><\/p>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-blue\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Donn\u00e9es bas\u00e9es sur les tests de diagnostic de routine<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><p><span style=\"font-weight: 400\">EEQ et donn\u00e9es cliniques publi\u00e9es<\/span><\/p>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Suivi de la performance apr\u00e8s commercialisation (PMPF)<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><p><span style=\"font-weight: 400\">Collecte continue de preuves<\/span><\/p>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-blue\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">\u00c9valuation des performances<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><p>Int\u00e9gration des donn\u00e9es <a href=\"https:\/\/mdxcro.com\/fr\/?post_type=service&amp;p=12042\"><span style=\"font-weight: 400\">analytiques<\/span><\/a><span style=\"font-weight: 400\"> et cliniques<\/span><\/p>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">\u00c9tudes de diagnostic compagnon (CDx)<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><p><span style=\"font-weight: 400\">Validation d\u2019essais de<\/span> <a href=\"https:\/\/mdxcro.com\/services\/precision-medicine-companion-diagnostics\/\"><span style=\"font-weight: 400\">m\u00e9decine de pr\u00e9cision<\/span><\/a><\/p>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-black\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">\u00c9tudes de comparaison de m\u00e9thodes<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><p><span style=\"font-weight: 400\">Par rapport aux m\u00e9thodes de r\u00e9f\u00e9rence \u00e9tablies<\/span><\/p>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                <\/div>\n                  \n          \n\n            <\/div>\n<\/section>\n<section class=\"table\"><div class=\"container\"><div class=\"headline\">Notre \u00e9quipe clinique poss\u00e8de une vaste exp\u00e9rience sur diverses plateformes de diagnostic<\/div><div class=\"table-wrapper\"><div class=\"feature-column-wrapper\"><table class=\"feature-table\"><thead><tr><th class=\"feature-column\">Technologie<\/th><\/tr><\/thead><tbody><tr><td class=\"feature-cell\"><strong>Diagnostic mol\u00e9culaire<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Immunoessais<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Histopathologie<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Point-of-Care (au chevet du patient)<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Logiciels et IA<\/strong><\/td><\/tr><\/tbody><\/table><\/div><div class=\"scrollable-columns-wrapper\"><table class=\"comparison-table\"><thead><tr><th class=\"column highlight\">Applications<\/th><\/tr><\/thead><tbody><tr><td class=\"cell highlight\">PCR, qPCR, PCR digitale, panels NGS<\/td><\/tr><tr><td class=\"cell highlight\">ELISA, chimiluminescence, multiplex<\/td><\/tr><tr><td class=\"cell highlight\">IHC, ISH, pathologie num\u00e9rique<\/td><\/tr><tr><td class=\"cell highlight\">Flux lat\u00e9ral, microfluidique, biocapteurs<\/td><\/tr><tr><td class=\"cell highlight\">Validation d\u2019algorithmes, SaMD, diagnostics num\u00e9riques<\/td><\/tr><\/tbody><\/table><\/div><\/div><\/div><\/section>\n<section class=\"key-stats\"  style=\"\">\n    <div class=\"container\">\n          <div class=\"headline\">Des r\u00e9sultats qui comptent<\/div>\n    \n    <div class=\"main-wrapper\">\n              <div class=\"box-grid\">\n                                    <div class=\"box\">\n                                  <div class=\"value\">100+<\/div>\n                                                  <div class=\"legend\">\u00e9tudes de performance clinique de DIV con\u00e7ues <\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">60+<\/div>\n                                                  <div class=\"legend\">soumissions d\u2019\u00e9tudes de performance dans des essais multi-pays<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">400+<\/div>\n                                                  <div class=\"legend\">documents d\u2019\u00e9tude essentiels \u00e9labor\u00e9s<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">30+  <\/div>\n                                                  <div class=\"legend\">\u00e9tudes IVDR en oncologie, maladies infectieuses, et plus encore<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">100%<\/div>\n                                                  <div class=\"legend\">taux de r\u00e9ussite des soumissions d\u2019\u00e9tudes de performance<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">9.4\/10<\/div>\n                                                  <div class=\"legend\">taux de satisfaction client<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">14<\/div>\n                                                  <div class=\"legend\">langues de l\u2019UE parl\u00e9es par notre \u00e9quipe<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">20+<\/div>\n                                                  <div class=\"legend\">pays incluant l\u2019UE et les \u00c9tats-Unis<\/div>\n                              <\/div>\n                              <\/div>\n      \n          <\/div>\n\n    <div class=\"data\">\n      \n          <\/div>\n  <\/div>\n<\/section>\n<section class=\"table\"><div class=\"container\"><div class=\"table-wrapper\"><div class=\"feature-column-wrapper\"><table class=\"feature-table\"><thead><tr><th class=\"feature-column\">Capacit\u00e9 : MDx vs CRO g\u00e9n\u00e9raliste<\/th><\/tr><\/thead><tbody><tr><td class=\"feature-cell\"><strong>Conception d\u2019\u00e9tude ISO 20916<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Expertise en preuves cliniques IVDR<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Soumissions aux comit\u00e9s d\u2019\u00e9thique et AC<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Suivi des \u00e9tudes de performance<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Repr\u00e9sentation l\u00e9gale dans l\u2019UE<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Documentation sp\u00e9cifique aux DIV<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Enregistrement EUDAMED<\/strong><\/td><\/tr><\/tbody><\/table><\/div><div class=\"scrollable-columns-wrapper\"><table class=\"comparison-table\"><thead><tr><th class=\"column highlight\">MDx CRO<\/th><th class=\"column\">Autres CRO<\/th><\/tr><\/thead><tbody><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Expertise sp\u00e9cialis\u00e9e<\/td><td class=\"cell\"><img decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Exp\u00e9rience limit\u00e9e<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Anciens experts d\u2019ON\/AC<\/td><td class=\"cell\"><img decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Souvent absente<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Taux de r\u00e9ussite de 100 %<\/td><td class=\"cell\"><img decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Exp\u00e9rience variable<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Moniteurs sp\u00e9cialis\u00e9s en DIV<\/td><td class=\"cell\"><img decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Souvent ax\u00e9s sur la pharma<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Service complet disponible<\/td><td class=\"cell\"><img decoding=\"async\" width=\"22\" height=\"22\" class=\"wp-image-7062 icon\" style=\"width: 22px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/x-1.svg\" alt=\"\">Rarement propos\u00e9s<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">CPSP, rapports de performance<\/td><td class=\"cell\"><img decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Mod\u00e8les g\u00e9n\u00e9riques<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Accompagnement complet<\/td><td class=\"cell\"><img decoding=\"async\" width=\"22\" height=\"22\" class=\"wp-image-7062 icon\" style=\"width: 22px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/x-1.svg\" alt=\"\">Conseils limit\u00e9s<\/td><\/tr><\/tbody><\/table><\/div><\/div><\/div><\/section>\n<section id=\"block_4ff9375b7db465bda8907d9c6579bd39\" class=\"testimonials\" style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/design-sponsor.jpg&#039;);\">\n        <div class=\"testimonials--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/design-sponsor.jpg\" alt=\"\" \/>\n    <\/div>\n    <div class=\"container\">\n                    <div class=\"headline\">T\u00e9moignage client<\/div>\n        \n                    <div class=\"slider\">\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">\u00ab\u00a0Delegating device sponsor responsibilities to MDx significantly improved our clinical trial operations. It allowed us to streamline our studies, ensuring fast study approvals in several countries and compliance with ISO 20916. Their team&rsquo;s ability to fill our internal knowledge gap on deviceregulations was invaluable.\u00a0\u00bb<\/p>\n                                                                            <p class=\"author\">\n                                Senior Director, Clinical Projects                                                                <br>\n                                Top 10 Global IVD Manufacturer                                        \n                            <\/p>\n                                            <\/div>\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">\u00ab\u00a0MDx guided us through our first European performance study. Their knowledge of ISO 20916 requirements and their support with site training gave us confidence that nothing was overlooked.\u00a0\u00bb<\/p>\n                                                                            <p class=\"author\">\n                                Clinical Operations Manager                                                                <br>\n                                Mid-Size Molecular Diagnostics Company                                        \n                            <\/p>\n                                            <\/div>\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">\u00ab\u00a0What stood out was your responsiveness. Whenever questions came from investigators or regulators, MDx provided clear answers quickly. It kept our study on schedule and reduced stress for our team.\u00a0\u00bb<\/p>\n                                                                            <p class=\"author\">\n                                Head of Regulatory Affairs                                                                 <br>\n                                Specialty Diagnostics Firm                                        \n                            <\/p>\n                                            <\/div>\n                            <\/div>\n        \n        <div class=\"footer\">\n            <div class=\"slider-dots\"><\/div>\n            <div class=\"button-wrapper\">\n                            <\/div>\n        <\/div>\n    <\/div>\n<\/section>\n\n<section id=\"block_4cb304bb6c11eb993e1dd9bfa125058e\" class=\"faqs\" style=\"padding-top: Par d\u00e9faut; padding-bottom: Par d\u00e9faut; margin-top: Par d\u00e9faut; margin-bottom: Par d\u00e9faut; \">\n    <div class=\"container\">\n    <div class=\"content\">\n      <div class=\"column\">\n                  <h2 class=\"headline\">Questions fr\u00e9quemment pos\u00e9es<\/h2>\n                          <a class=\"button button--default\" href=\"https:\/\/mdxcro.com\/fr\/contact\/?utm_content=service_ivd_clinical_studies\" target=\"\">\n            Posez-nous une question          <\/a>\n              <\/div>\n      <div class=\"column\">\n                  <ul class=\"faq-list\">\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Quelle est la diff\u00e9rence entre un essai clinique et une \u00e9tude de performance de DIV ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Bien que les deux \u00e9valuent la performance d\u2019un dispositif, les \u00e9tudes de performance de DIV suivent des r\u00e9glementations sp\u00e9cifiques (IVDR, ISO 20916) plut\u00f4t que les cadres traditionnels des essais cliniques (ICH-GCP). Les \u00e9tudes de DIV se concentrent g\u00e9n\u00e9ralement sur l\u2019\u00e9valuation de la performance clinique d\u2019un essai \u00e0 l\u2019aide d\u2019\u00e9chantillons existants ou nouvellement collect\u00e9s, plut\u00f4t que sur le test d\u2019interventions sur des patients. <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">MDx peut-elle g\u00e9rer les soumissions aux comit\u00e9s d\u2019\u00e9thique et aux autorit\u00e9s comp\u00e9tentes ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Oui, nous g\u00e9rons tous les aspects des soumissions aux comit\u00e9s d\u2019\u00e9thique (CE\/IRB) et des demandes aupr\u00e8s des autorit\u00e9s comp\u00e9tentes. Notre \u00e9quipe affiche un taux de r\u00e9ussite de 100 % dans l\u2019obtention d\u2019approbations dans plusieurs pays europ\u00e9ens pour les \u00e9tudes de performance IVDR. <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">MDx propose-t-elle une repr\u00e9sentation l\u00e9gale pour les \u00e9tudes cliniques de DIV en Europe ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Oui, nous fournissons des services complets de repr\u00e9sentation l\u00e9gale pour les promoteurs hors UE menant des \u00e9tudes en vertu de l\u2019article 58 de l\u2019IVDR. Cela inclut la gestion de toutes les communications r\u00e9glementaires, les rapports de s\u00e9curit\u00e9 et les responsabilit\u00e9s de conformit\u00e9. <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\"> Qu\u2019est-ce qu\u2019un CPSP sous l\u2019IVDR ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Un protocole d\u2019\u00e9tude de performance clinique (CPSP) est un document obligatoire pour les \u00e9tudes de performance de DIV sous l\u2019IVDR. Il d\u00e9taille la conception de l\u2019\u00e9tude, les objectifs, la s\u00e9lection des participants, la manipulation des \u00e9chantillons, l\u2019analyse statistique et les proc\u00e9dures de qualit\u00e9 conform\u00e9ment aux exigences de l\u2019ISO 20916 et des Annexes XIII\/XIV de l\u2019IVDR. <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Comment MDx g\u00e8re-t-elle les rapports de s\u00e9curit\u00e9 dans les \u00e9tudes de performance de DIV ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Nous mettons en \u0153uvre des syst\u00e8mes robustes pour le suivi et le signalement des \u00e9v\u00e9nements ind\u00e9sirables et des d\u00e9faillances de dispositifs conform\u00e9ment aux exigences de l\u2019IVDR, avec des circuits d\u2019escalade clairs, des d\u00e9lais de signalement et des proc\u00e9dures de documentation.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Pouvez-vous soutenir des \u00e9tudes de DIV multi-pays ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Absolument. Nous poss\u00e9dons une vaste exp\u00e9rience dans la coordination d\u2019\u00e9tudes dans plusieurs pays, l\u2019harmonisation des soumissions et la gestion de r\u00e9seaux de sites \u00e0 travers l\u2019Europe, l\u2019Am\u00e9rique du Nord et la r\u00e9gion APAC. <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Qu\u2019est-ce qu\u2019une CRO sp\u00e9cialis\u00e9e en DIV ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p>Une CRO sp\u00e9cialis\u00e9e en DIV (organisme de recherche sous contrat pour le diagnostic in vitro) est un prestataire de services sp\u00e9cialis\u00e9 qui accompagne les entreprises dans le d\u00e9veloppement, la validation et la mise sur le march\u00e9 de tests de diagnostic, lesquels sont effectu\u00e9s sur des \u00e9chantillons tels que le sang ou les tissus en dehors du corps humain. Ces organisations aident \u00e0 la <a href=\"https:\/\/mdxcro.com\/fr\/services\/recherche-clinique\/\">recherche clinique<\/a>, aux \u00e9tudes cliniques, \u00e0 la conformit\u00e9 r\u00e9glementaire (comme les approbations d\u2019autorit\u00e9s telles que la <span class=\"hover:entity-accent entity-underline inline cursor-pointer align-baseline\"><span class=\"whitespace-normal\">FDA<\/span><\/span> ou l\u2019<span class=\"hover:entity-accent entity-underline inline cursor-pointer align-baseline\"><span class=\"whitespace-normal\">Agence europ\u00e9enne des m\u00e9dicaments<\/span><\/span>), \u00e0 l\u2019\u00e9valuation des performances et \u00e0 l\u2019assurance qualit\u00e9. En termes simples, une CRO sp\u00e9cialis\u00e9e en DIV agit comme un partenaire expert externe qui guide les entreprises de diagnostic \u00e0 travers le processus complexe consistant \u00e0 prouver que leurs tests sont s\u00fbrs, pr\u00e9cis et pr\u00eats pour une utilisation commerciale.  <\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Comment choisir une CRO sp\u00e9cialis\u00e9e en DIV ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p>Dans le monde hautement r\u00e9glement\u00e9 et comp\u00e9titif du d\u00e9veloppement de dispositifs m\u00e9dicaux, le choix d\u2019un organisme de recherche clinique (CRO) est plus qu\u2019une d\u00e9cision commerciale, c\u2019est un partenariat strat\u00e9gique crucial pour le succ\u00e8s. Une CRO qualifi\u00e9e pour les dispositifs m\u00e9dicaux apporte une expertise inestimable dans les investigations cliniques, la navigation r\u00e9glementaire et les strat\u00e9gies d\u2019entr\u00e9e sur le march\u00e9, agissant comme un pivot pour les processus de d\u00e9veloppement et d\u2019approbation.<br \/>\n<a href=\"https:\/\/mdxcro.com\/medical-device-cro-how-to-qualify-your-clinical-partner\/\">Consultez notre guide pour choisir votre CRO sp\u00e9cialis\u00e9e en DIV.<\/a><\/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\":\"Quelle est la diff\u00e9rence entre un essai clinique et une \u00e9tude de performance de DIV ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Bien que les deux \u00e9valuent la performance d\u2019un dispositif, les \u00e9tudes de performance de DIV suivent des r\u00e9glementations sp\u00e9cifiques (IVDR, ISO 20916) plut\u00f4t que les cadres traditionnels des essais cliniques (ICH-GCP). 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Nous poss\u00e9dons une vaste exp\u00e9rience dans la coordination d\u2019\u00e9tudes dans plusieurs pays, l\u2019harmonisation des soumissions et la gestion de r\u00e9seaux de sites \u00e0 travers l\u2019Europe, l\u2019Am\u00e9rique du Nord et la r\u00e9gion APAC.\"}},{\"@type\":\"Question\",\"name\":\"Qu\u2019est-ce qu\u2019une CRO sp\u00e9cialis\u00e9e en DIV ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Une CRO sp\u00e9cialis\u00e9e en DIV (organisme de recherche sous contrat pour le diagnostic in vitro) est un prestataire de services sp\u00e9cialis\u00e9 qui accompagne les entreprises dans le d\u00e9veloppement, la validation et la mise sur le march\u00e9 de tests de diagnostic, lesquels sont effectu\u00e9s sur des \u00e9chantillons tels que le sang ou les tissus en dehors du corps humain. Ces organisations aident \u00e0 la recherche clinique, aux \u00e9tudes cliniques, \u00e0 la conformit\u00e9 r\u00e9glementaire (comme les approbations d\u2019autorit\u00e9s telles que la FDA ou l\u2019Agence europ\u00e9enne des m\u00e9dicaments), \u00e0 l\u2019\u00e9valuation des performances et \u00e0 l\u2019assurance qualit\u00e9. En termes simples, une CRO sp\u00e9cialis\u00e9e en DIV agit comme un partenaire expert externe qui guide les entreprises de diagnostic \u00e0 travers le processus complexe consistant \u00e0 prouver que leurs tests sont s\u00fbrs, pr\u00e9cis et pr\u00eats pour une utilisation commerciale.\"}},{\"@type\":\"Question\",\"name\":\"Comment choisir une CRO sp\u00e9cialis\u00e9e en DIV ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Dans le monde hautement r\u00e9glement\u00e9 et comp\u00e9titif du d\u00e9veloppement de dispositifs m\u00e9dicaux, le choix d\u2019un organisme de recherche clinique (CRO) est plus qu\u2019une d\u00e9cision commerciale, c\u2019est un partenariat strat\u00e9gique crucial pour le succ\u00e8s. Une CRO qualifi\u00e9e pour les dispositifs m\u00e9dicaux apporte une expertise inestimable dans les investigations cliniques, la navigation r\u00e9glementaire et les strat\u00e9gies d\u2019entr\u00e9e sur le march\u00e9, agissant comme un pivot pour les processus de d\u00e9veloppement et d\u2019approbation.\\nConsultez notre guide pour choisir votre CRO sp\u00e9cialis\u00e9e en DIV.\"}}]}  <\/script>\n\n<section id=\"block_fb86865f4f8b8263e302d54a817b9429\" class=\"text-image\" style=\"\">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">Responsable DIV : Carlos Galamba<\/h2><div class=\"description wysiwyg\"><p>Avec plus de 18 ans d\u2019exp\u00e9rience dans le secteur des DIV, incluant un travail pratique en tant que scientifique en m\u00e9decine transfusionnelle et diagnostic des maladies infectieuses, ainsi qu\u2019une exp\u00e9rience d\u2019examen r\u00e9glementaire au BSI, l\u2019un des plus grands organismes notifi\u00e9s de l\u2019UE, Carlos Galamba apporte une perspective int\u00e9gr\u00e9e unique \u00e0 la strat\u00e9gie r\u00e9glementaire des DIV. Son travail couvre les DIV de classe C\/D, les diagnostics compagnons, les essais bas\u00e9s sur le NGS et les DIV bas\u00e9s sur des logiciels, avec un r\u00f4le actuel de conseiller aupr\u00e8s de la Commission europ\u00e9enne sur les questions r\u00e9glementaires. Chez MDx CRO, il dirige la strat\u00e9gie r\u00e9glementaire pour les programmes de DIV complexes sur les march\u00e9s de l\u2019UE (IVDR), de la FDA et mondiaux.  <\/p>\n<\/div><a class=\"button\" href=\"https:\/\/bookings.cloud.microsoft\/book\/BookaMeetingwithMDx@mdxcro.com\/s\/y5lEPzgB7kCx1UiOi1V6ig2?ismsaljsauthenabled=true\" target=\"_self\">Prendre rendez-vous avec Carlos Galamba<\/a><\/div><\/div>                            <div class=\"column column--image\"><img decoding=\"async\" class=\"image\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/10\/Carlos-Galamba-2.jpg\" alt=\"High-quality professional portrait of a confident male healthcare professional in a bright modern medical office, emphasizing MedTech innovation and healthcare excellence.\"  \/><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n<section id=\"block_6966556dddbd17692adfe1eba72ba6ad\" class=\"call-to-action\" style=\"padding-top: Par d\u00e9faut; padding-bottom: Par d\u00e9faut; margin-top: Par d\u00e9faut; margin-bottom: Par d\u00e9faut; \">\n        <div class=\"call-to-action--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/mdx-cta-bg.png\" alt=\"\" \/>\n    <\/div>\n    <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"content\">\n                                    <h2 class=\"title\">Associez-vous aux experts leaders en \u00e9tudes cliniques de CRO sp\u00e9cialis\u00e9e en DIV en Europe<\/h2>\n                \n                                    <div class=\"description wysiwyg\">\n                        <p><span style=\"font-weight: 400;\">Que vous planifiiez votre premi\u00e8re \u00e9tude de performance IVDR ou que vous g\u00e9riez un programme mondial d\u2019\u00e9valuation clinique, MDx apporte l\u2019expertise, les ressources et les connaissances r\u00e9glementaires n\u00e9cessaires pour garantir votre succ\u00e8s.<\/span><\/p>\n<p><b>Du protocole au rapport de performance. Nous tenons nos promesses. <\/b><\/p>\n                    <\/div>\n                            <\/div>\n\n                            <div class=\"button-wrapper\">\n                                                                        <a href=\"https:\/\/mdxcro.com\/fr\/contact\/?utm_content=service_ivd_clinical_studies\" class=\"button button--secondary\" target=\"\">\n                                Contactez-nous                            <\/a>\n                                                                                                <a href=\"https:\/\/mdxcro.com\/running-clinical-studies-under-ivdr-what-you-need-to-know\/\" class=\"button button--tertiary\" target=\"\">\n                                Lire notre guide sur les \u00e9tudes cliniques                            <\/a>\n                                                            <\/div>\n                    <\/div>\n    <\/div>\n<\/section>\n\n<script type=\"application\/ld+json\">{\n  \"@context\": \"https:\/\/schema.org\",\n  \"@type\": \"Service\",\n  \"serviceType\": \"IVD Clinical Studies and Performance Evaluation\",\n  \"provider\": {\n    \"@type\": \"Organization\",\n    \"name\": \"MDx CRO\",\n    \"url\": \"https:\/\/www.mdxcro.com\",\n    \"logo\": \"https:\/\/www.mdxcro.com\/wp-content\/uploads\/logo.png\",\n    \"description\": \"European CRO specializing in IVD and medical device regulatory consulting\"\n  },\n  \"areaServed\": [\n    {\n      \"@type\": \"Place\",\n      \"name\": \"European Union\"\n    },\n    {\n      \"@type\": \"Place\", \n      \"name\": \"United States\"\n    },\n    {\n      \"@type\": \"Place\",\n      \"name\": \"Asia\"\n    }\n  ],\n  \"description\": \"Comprehensive IVD clinical studies services including performance evaluation, analytical validation, and clinical evidence generation for IVDR compliance and market access in Europe.\",\n  \"hasOfferCatalog\": {\n    \"@type\": \"OfferCatalog\",\n    \"name\": \"IVD Clinical Studies Services\",\n    \"itemListElement\": [\n      {\n        \"@type\": \"Offer\",\n        \"itemOffered\": {\n          \"@type\": \"Service\",\n          \"name\": \"IVDR Performance Evaluation\"\n        }\n      },\n      {\n        \"@type\": \"Offer\",\n        \"itemOffered\": {\n          \"@type\": \"Service\",\n          \"name\": \"Clinical Evidence Generation\"\n        }\n      },\n      {\n        \"@type\": \"Offer\",\n        \"itemOffered\": {\n          \"@type\": \"Service\",\n          \"name\": \"Analytical Validation Studies\"\n        }\n      }\n    ]\n  }\n}\n<\/script>\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"featured_media":0,"parent":0,"menu_order":0,"template":"","meta":{"_acf_changed":false},"class_list":["post-12057","service","type-service","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>\u00c9tudes de performance clinique des DIV | IVDR, FDA | Cadres mondiaux<\/title>\n<meta name=\"description\" content=\"MDx propose des services complets d\u2019\u00e9tudes cliniques pour DIV sous IVDR, FDA et ISO 20916 : conception de protocoles, soumissions selon l\u2019Annexe XIV, approbations des comit\u00e9s d\u2019\u00e9thique, essais combin\u00e9s m\u00e9dicament-diagnostic et rapports de s\u00e9curit\u00e9. 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