{"id":12100,"date":"2025-07-29T14:17:18","date_gmt":"2025-07-29T14:17:18","guid":{"rendered":"https:\/\/mdxcro.com\/sectors\/ivd-de-bout-en-bout\/"},"modified":"2026-07-22T10:06:14","modified_gmt":"2026-07-22T10:06:14","slug":"ivd-de-bout-en-bout","status":"publish","type":"sector","link":"https:\/\/mdxcro.com\/fr\/sectors\/ivd-de-bout-en-bout\/","title":{"rendered":"Services DIV de bout en bout"},"content":{"rendered":"\n<section id=\"block_cab9216560aad6435d79d9834e698810\" 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\">Services d&rsquo;ORC DIV complets pour l&rsquo;IVDR et la FDA<\/h1>\n            \n                            <div class=\"description\"><p><span style=\"font-weight: 400;\">De la strat\u00e9gie r\u00e9glementaire et du d\u00e9veloppement d&rsquo;essais \u00e0 la validation clinique, au marquage CE et au soutien post-commercialisation, MDx CRO est votre partenaire ORC DIV tout au long du cycle de vie complet.<\/span><\/p>\n<\/div>\n            \n                            <div class=\"button-wrapper\">\n                                            <a href=\"https:\/\/mdxcro.com\/fr\/contact\/?utm_source=ind_end_to_end\" class=\"button button--default\" target=\"_blank\">\n                            Contactez-nous                        <\/a>\n                                            <a href=\"#process\" class=\"button button--secondary\" target=\"_self\">\n                            D\u00e9couvrez notre processus                        <\/a>\n                                    <\/div>\n                            <\/div>\n            <\/div>\n<\/section>\n\n<section id=\"block_16ad9672386a9885f560073701a3e82b\" 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\">Expertise ORC DIV compl\u00e8te pour la r\u00e9ussite commerciale<\/h2><div class=\"description wysiwyg\"><p><span style=\"font-weight: 400\">Nous guidons les fabricants de DIV \u00e0 travers chaque phase, du concept et du d\u00e9veloppement de produits \u00e0 la conformit\u00e9 IVDR et FDA, \u00e0 la validation clinique et \u00e0 la surveillance post-commercialisation. Que vous lanciez un nouvel essai, un instrument DIV ou que vous mettiez \u00e0 jour la documentation technique, notre <strong>ORC DIV assure la conformit\u00e9, la rapidit\u00e9 et la pr\u00e9paration au march\u00e9 mondial<\/strong>. <\/span><\/p>\n<p>Nos \u00e9quipes int\u00e8grent l&rsquo;expertise r\u00e9glementaire, analytique, clinique et biostatistique selon la norme ISO 20916 pour r\u00e9duire les risques des programmes et acc\u00e9l\u00e9rer les approbations.<\/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<section id=\"block_3c3b4396f796f6a6d4bdb7586a27fa5f\" class=\"tabs\" style=\"padding-top: var(--wp--preset--spacing--regular);\">\n        <div class=\"container\">\n                    <div class=\"title\">Services d&#039;ORC DIV : Analytiques, Cliniques et R\u00e9glementaires<\/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=\"affaires-reglementaires-et-documentation-technique\">\n                    Affaires r\u00e9glementaires et documentation technique                <\/button>\n                            <button class=\"tab-button\" data-tab=\"etudes-analytiques-div\">\n                    \u00c9tudes analytiques DIV                 <\/button>\n                            <button class=\"tab-button\" data-tab=\"etudes-cliniques-div\">\n                    \u00c9tudes cliniques DIV                <\/button>\n                            <button class=\"tab-button\" data-tab=\"ingenierie-de-lutilisabilite-et-facteurs-humains\">\n                    Ing\u00e9nierie de l&#039;utilisabilit\u00e9 et facteurs humains                <\/button>\n                            <button class=\"tab-button\" data-tab=\"services-de-representation\">\n                    Services de repr\u00e9sentation                <\/button>\n                    <\/div>\n\n        <!-- Tab Content -->\n        <div class=\"tab-content-wrapper\">\n                            <div class=\"tab-content active\" id=\"affaires-reglementaires-et-documentation-technique\">\n                    <div class=\"tab-grid\">\n                        <div class=\"tab-left\">\n                            <h3>Affaires r\u00e9glementaires et documentation technique<\/h3>\n                            <div class=\"description wysiwyg\">\n                                <p><a href=\"https:\/\/mdxcro.com\/fr\/services\/affaires-reglementaires-documentation-technique\/\"><strong>Un accompagnement complet de la strat\u00e9gie \u00e0 la soumission et \u00e0 la conformit\u00e9 post-commercialisation<\/strong><\/a><\/p>\n<p>\u2022 Strat\u00e9gie r\u00e9glementaire et d\u00e9finition de la voie d&rsquo;acc\u00e8s au march\u00e9<br \/>\n\u2022 Classification des DIV, exigences g\u00e9n\u00e9rales en mati\u00e8re de s\u00e9curit\u00e9 et de performances (GSPR) et gestion des risques ISO 14971<br \/>\n\u2022 Marquage CE et engagement de l&rsquo;organisme notifi\u00e9<br \/>\n\u2022 Soumissions r\u00e9glementaires 510(k), PMA et mondiales<br \/>\n\u2022 Enregistrement EUDAMED et conseil UDI<br \/>\n\u2022 Dossiers de conception (DHF) et documentation technique<br \/>\n\u2022 Plans d&rsquo;\u00e9valuation des performances (PEP) et rapports (PER)<br \/>\n\u2022 Preuves cliniques et rapports de validit\u00e9 scientifique (SVR)<br \/>\n\u2022 R\u00e9sum\u00e9 des donn\u00e9es de s\u00e9curit\u00e9 et de performances (SSP)<br \/>\n\u2022 D\u00e9veloppement de l&rsquo;\u00e9tiquetage et des notices d&rsquo;utilisation (IFU)<br \/>\n\u2022 Surveillance post-commercialisation (PMS, PMPF, PSUR)<\/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\">Pr\u00e9c\u00e9dent<\/button>\n                        <button class=\"nav-button next-button\">\n                            Continue to Affaires r\u00e9glementaires et documentation technique                        <\/button>\n                    <\/div>\n                <\/div>\n                            <div class=\"tab-content\" id=\"etudes-analytiques-div\">\n                    <div class=\"tab-grid\">\n                        <div class=\"tab-left\">\n                            <h3>\u00c9tudes analytiques DIV <\/h3>\n                            <div class=\"description wysiwyg\">\n                                <p><a href=\"https:\/\/mdxcro.com\/fr\/services\/etudes-analytiques-ivd\/\"><strong>Un accompagnement complet pour la conception, la v\u00e9rification et la validation analytique des essais<\/strong><\/a><\/p>\n<p>\u2022 Planification de la validation analytique<br \/>\n\u2022 D\u00e9veloppement de produits DIV et validation d&rsquo;essais\u2022 D\u00e9veloppement d&rsquo;essais de biomarqueurs et mol\u00e9culaires (PCR, LFA, NGS)<br \/>\n\u2022 Rapports de performances analytiques (APR)<br \/>\n\u2022 Conformit\u00e9 CLSI<br \/>\n\u2022 \u00c9tudes de stabilit\u00e9<\/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\">Pr\u00e9c\u00e9dent<\/button>\n                        <button class=\"nav-button next-button\">\n                            Continue to \u00c9tudes analytiques DIV                         <\/button>\n                    <\/div>\n                <\/div>\n                            <div class=\"tab-content\" id=\"etudes-cliniques-div\">\n                    <div class=\"tab-grid\">\n                        <div class=\"tab-left\">\n                            <h3>\u00c9tudes cliniques DIV<\/h3>\n                            <div class=\"description wysiwyg\">\n                                <p><a href=\"https:\/\/mdxcro.com\/fr\/services\/etudes-cliniques-sur-les-dispositifs-medicaux-de-diagnostic-in-vitro\/\"><strong>Un accompagnement complet pour l&rsquo;\u00e9valuation des performances cliniques<\/strong><\/a><\/p>\n<p>\u2022 Conception d&rsquo;\u00e9tudes et de protocoles<br \/>\n\u2022 \u00c9tudes de performances cliniques et gestion des sites<br \/>\n\u2022 Surveillance des \u00e9tudes DIV<br \/>\n\u2022 Biostatistiques et gestion des donn\u00e9es<br \/>\n\u2022 Conception d&rsquo;eCRF et d&rsquo;eTMF<br \/>\n\u2022 Conformit\u00e9 ISO 20916<\/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\">Pr\u00e9c\u00e9dent<\/button>\n                        <button class=\"nav-button next-button\">\n                            Continue to \u00c9tudes cliniques DIV                        <\/button>\n                    <\/div>\n                <\/div>\n                            <div class=\"tab-content\" id=\"ingenierie-de-lutilisabilite-et-facteurs-humains\">\n                    <div class=\"tab-grid\">\n                        <div class=\"tab-left\">\n                            <h3>Ing\u00e9nierie de l&#039;utilisabilit\u00e9 et facteurs humains<\/h3>\n                            <div class=\"description wysiwyg\">\n                                <p><a href=\"https:\/\/mdxcro.com\/fr\/services\/ingenierie-de-l-aptitude-a-l-utilisation\/\"><strong>Concevoir pour la s\u00e9curit\u00e9 de l&rsquo;utilisateur et la conformit\u00e9 sur tous les formats de DIV<\/strong><\/a><\/p>\n<p>\u2022 Conformit\u00e9 IEC 62366<br \/>\n\u2022 Tests d&rsquo;utilisabilit\u00e9 formatifs et sommatifs<br \/>\n\u2022 Protocoles d&rsquo;utilisabilit\u00e9 et \u00e9tudes de compr\u00e9hension des \u00e9tiquettes<br \/>\n\u2022 \u00c9tudes d&rsquo;utilisabilit\u00e9 pour les DIV au point de service<br \/>\n\u2022 Recrutement de participants<\/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\">Pr\u00e9c\u00e9dent<\/button>\n                        <button class=\"nav-button next-button\">\n                            Continue to Ing\u00e9nierie de l&rsquo;utilisabilit\u00e9 et facteurs humains                        <\/button>\n                    <\/div>\n                <\/div>\n                            <div class=\"tab-content\" id=\"services-de-representation\">\n                    <div class=\"tab-grid\">\n                        <div class=\"tab-left\">\n                            <h3>Services de repr\u00e9sentation<\/h3>\n                            <div class=\"description wysiwyg\">\n                                <p><a href=\"https:\/\/mdxcro.com\/fr\/services\/services-de-representation\/\"><strong>Acc\u00e8s au march\u00e9 de l&rsquo;UE et du Royaume-Uni gr\u00e2ce \u00e0 une repr\u00e9sentation locale<\/strong><\/a><\/p>\n<p>\u2022 Repr\u00e9sentant autoris\u00e9 de l&rsquo;UE (EC Rep)<br \/>\n\u2022 Personne responsable du Royaume-Uni (UK RP)<br \/>\n\u2022 Interface avec les autorit\u00e9s et les organismes notifi\u00e9s<br \/>\n\u2022 Soutien \u00e0 l&rsquo;\u00e9tiquetage et \u00e0 la vigilance<\/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\">Pr\u00e9c\u00e9dent<\/button>\n                        <button class=\"nav-button next-button\">\n                            Continue to Services de repr\u00e9sentation                        <\/button>\n                    <\/div>\n                <\/div>\n                    <\/div>\n    <\/div>\n<\/section>\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\">Notre ORC DIV : Du concept au march\u00e9<\/h2>\n            \n            \n                    <\/div>\n\n                    <div class=\"grid\">\n                                    <div class=\"card card--background-blue\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Strat\u00e9gie r\u00e9glementaire<\/div>\n                        <div class=\"back\"><p>D\u00e9finir la voie r\u00e9glementaire, la classification des dispositifs et la strat\u00e9gie de march\u00e9 r\u00e9gionale.<\/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\">D\u00e9veloppement d&#039;essais ou de logiciels<\/div>\n                        <div class=\"back\"><p>Concevez et validez votre essai, votre logiciel ou votre produit DIV pour les performances analytiques et fonctionnelles.<\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-white\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Validation clinique<\/div>\n                        <div class=\"back\"><p>Planifier et ex\u00e9cuter des \u00e9tudes de performances cliniques conform\u00e9ment aux exigences ISO 20916, IVDR et FDA.<\/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\">Documentation technique<\/div>\n                        <div class=\"back\"><p>Compiler la documentation technique IVDR ou le dossier de conception FDA, y compris l&rsquo;\u00e9tiquetage et l&rsquo;analyse des risques.<\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-black\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Soumission r\u00e9glementaire<\/div>\n                        <div class=\"back\"><p>Pr\u00e9parer et soumettre les dossiers pour le marquage CE, le 510(k) ou le PMA, et soutenir les interactions avec l&rsquo;organisme notifi\u00e9 ou la FDA.<\/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\">Soutien post-commercialisation<\/div>\n                        <div class=\"back\"><p>Maintenir la conformit\u00e9 gr\u00e2ce \u00e0 la PMS, aux PSUR, aux \u00e9tudes PMPF et aux rapports EUDAMED\/UDI.<\/p>\n<\/div>\n                    <\/div>\n                            <\/div>\n        \n            <\/div>\n<\/section>\n<section id=\"block_431ff8abc0ea8f2bd7feb01f52cc8f10\" class=\"content-columns content-columns--three-columns content-columns--background-white\" style=\"\">\n        <div class=\"container\">\n                    <div class=\"content\">\n                                    <h2 class=\"title\">Notre expertise DIV<\/h2>\n                                                    <div class=\"description wysiwyg\">\n                        <p>En tant qu&rsquo;ORC DIV sp\u00e9cialis\u00e9e, nous soutenons de multiples domaines scientifiques, applications et 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\">Domaines scientifiques<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li>M\u00e9decine de pr\u00e9cision et diagnostics compagnons<\/li>\n<li>Tests g\u00e9n\u00e9tiques<\/li>\n<li>D\u00e9pistage du cancer<\/li>\n<li>Maladies infectieuses<\/li>\n<li>Marqueurs physiologiques<\/li>\n<li>H\u00e9matologie et h\u00e9mostase<\/li>\n<li>M\u00e9decine transfusionnelle<\/li>\n<li>Biochimie, microbiologie et plus<\/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>Usage professionnel<\/li>\n<li>Point de service<\/li>\n<li>Autotests<\/li>\n<li>Logiciels DIV<\/li>\n<li>Tests d\u00e9velopp\u00e9s en laboratoire (\u00c9tats-Unis)<\/li>\n<li>Essais internes (UE)<\/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>Mol\u00e9culaire<\/li>\n<li>Immunoessais<\/li>\n<li>Immunohistochimie<\/li>\n<li>Multiplex<\/li>\n<li>Flux lat\u00e9ral<\/li>\n<li>Microfluidique et plus<\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                <\/div>\n                  \n          \n\n            <\/div>\n<\/section>\n\n<section id=\"block_da64221be81d700680f3256b0568b09a\" 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\" alt=\"\" \/>\n    <\/div>\n    <div class=\"container\">\n                    <div class=\"headline\">Pourquoi les \u00e9quipes de diagnostic choisissent-elles MDx comme leur ORC DIV ?<\/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\">Voir les \u00e9tudes de cas<\/a>\n            <\/div>\n        <\/div>\n    <\/div>\n<\/section>\n\n<section id=\"block_05987770811413539fc47c8635f3c3ff\" class=\"content-columns content-columns--three-columns content-columns--background-white\" style=\"\">\n        <div class=\"container\">\n                    <div class=\"content\">\n                                    <h2 class=\"title\">Qui nous <span class=\"blue-highlight\"> soutenons <\/span> en tant qu&rsquo;ORC DIV<\/h2>\n                                            <\/div>\n        \n                    <div class=\"grid\">\n                                                        <div class=\"card card--background-white-frost\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Innovateurs et start-ups en diagnostic pr\u00e9coce<\/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\">Fabricants mondiaux de DIV<\/h3>\n                                                                                <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white-frost\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Entreprises de m\u00e9decine de pr\u00e9cision<\/h3>\n                                                                                <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white-frost\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Entreprises de sant\u00e9 num\u00e9rique et d&rsquo;IA<\/h3>\n                                                                                <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white-frost\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Entreprises am\u00e9ricaines recherchant un acc\u00e8s \u00e0 l&rsquo;IVDR de l&rsquo;UE<\/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\">Entreprises pharmaceutiques et biotechnologiques d\u00e9veloppant des CDx<\/h3>\n                                                                                <\/div>\n                                                                    <\/div>\n                                                <\/div>\n                  \n          \n\n            <\/div>\n<\/section>\n\n<section id=\"block_1fece1723cd89f378041b8d1914de832\" 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\">Voir les \u00e9tudes de cas<\/a>\n            <\/div>\n        <\/div>\n    <\/div>\n<\/section>\n<section id=\"block_9a0ed4d4933a53ac1f7acc3e994c079f\" 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--quaternary\" href=\"https:\/\/mdxcro.com\/fr\/contact\/\" 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\">Comment une ORC DIV m\u00e8ne-t-elle des \u00e9tudes de performances cliniques ISO 20916 ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p>Nous d\u00e9finissons les crit\u00e8res d&rsquo;\u00e9valuation et la conception de l&rsquo;\u00e9tude, \u00e9laborons les protocoles et les eCRF, qualifions les sites, surveillons la conduite, g\u00e9rons les donn\u00e9es et les biostatistiques, et compilons les preuves cliniques pour le rapport d&rsquo;\u00e9valuation des performances. Notre approche s&rsquo;aligne sur l&rsquo;Annexe XIII\/XIV de l&rsquo;IVDR et les attentes des organismes notifi\u00e9s. <\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Que fait une ORC DIV ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><strong>Une ORC DIV con\u00e7oit et ex\u00e9cute des activit\u00e9s de performances analytiques et cliniques, pr\u00e9pare la documentation technique et soutient les soumissions IVDR et FDA.<\/strong>  Chez MDx CRO, nous int\u00e9grons la r\u00e9glementation, la biostatistique, la gestion de site et la qualit\u00e9 pour fournir des preuves conformes \u00e0 la norme ISO 20916 pour le marquage CE et les approbations am\u00e9ricaines.<\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Les \u00e9tudes cliniques sont-elles requises pour la conformit\u00e9 \u00e0 l&#039;IVDR de l&#039;UE ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Pas toujours. En vertu de l&rsquo;IVDR de l&rsquo;UE, les performances cliniques doivent \u00eatre d\u00e9montr\u00e9es par une ou plusieurs des sources suivantes : <\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400\">\u00c9tudes de performances cliniques (Annexe XIII et Annexe XIV),<\/span><\/li>\n<\/ul>\n<ul>\n<li><span style=\"font-weight: 400\">Litt\u00e9rature scientifique pertinente pour l&rsquo;usage pr\u00e9vu du dispositif, ou<\/span><\/li>\n<\/ul>\n<ul>\n<li><span style=\"font-weight: 400\">Exp\u00e9rience publi\u00e9e issue de l&rsquo;utilisation diagnostique de routine.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400\">Les fabricants doivent planifier ces preuves dans le Plan d&rsquo;\u00e9valuation des performances (PEP) et les r\u00e9sumer dans le Rapport de performances cliniques (CPR) et le Rapport d&rsquo;\u00e9valuation des performances (PER). Bien que tous les DIV ne n\u00e9cessitent pas une nouvelle \u00e9tude clinique,   <\/span><i><span style=\"font-weight: 400\">au moins une de ces sources<\/span><\/i><span style=\"font-weight: 400\"> doit \u00eatre disponible et suffisante pour \u00e9tayer les performances cliniques revendiqu\u00e9es.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">MDx peut-il soutenir les transitions LDT vers DIV ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Oui, nous aidons les laboratoires et les d\u00e9veloppeurs de tests \u00e0 convertir les LDT en DIV conformes avec un soutien sur la documentation, la validation et la s\u00e9lection de la voie d&rsquo;acc\u00e8s au march\u00e9.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Combien de temps prend g\u00e9n\u00e9ralement le marquage CE ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">La plupart des clients atteignent la pr\u00e9paration au marquage CE en 6 \u00e0 18 mois, selon la classe de risque, la disponibilit\u00e9 des donn\u00e9es et la disponibilit\u00e9 de l&rsquo;organisme notifi\u00e9.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">O\u00f9 puis-je obtenir un soutien r\u00e9glementaire complet pour les programmes DIV-CDx ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p>Chez MDx CRO, nous fournissons un soutien r\u00e9glementaire et clinique complet et mondial, sp\u00e9cifiquement adapt\u00e9 aux diagnostics compagnons (CDx) et aux programmes de m\u00e9decine de pr\u00e9cision.<\/p>\n<p>Naviguer dans les doubles complexit\u00e9s du cod\u00e9veloppement m\u00e9dicament-diagnostic exige une expertise sp\u00e9cialis\u00e9e. Notre \u00e9quipe r\u00e9glementaire est id\u00e9alement positionn\u00e9e pour combler cette lacune : <\/p>\n<p>Experts d&rsquo;anciens organismes notifi\u00e9s : Notre \u00e9quipe comprend d&rsquo;anciens \u00e9valuateurs et experts techniques d&rsquo;organismes notifi\u00e9s qui comprennent exactement ce que les r\u00e9gulateurs europ\u00e9ens recherchent dans le cadre de l&rsquo;IVDR, minimisant ainsi les risques de soumission.<\/p>\n<p>Port\u00e9e strat\u00e9gique mondiale (FDA et IVDR) : Nous g\u00e9rons l&rsquo;ensemble du parcours r\u00e9glementaire, du marquage CE europ\u00e9en aux soumissions CDx de la FDA (y compris les pr\u00e9-soumissions, les IDE et les PMA), garantissant que le calendrier de votre diagnostic s&rsquo;aligne parfaitement avec les jalons th\u00e9rapeutiques de votre partenaire pharmaceutique.<\/p>\n<p>Expertise approfondie en MVDI et NGS : Nous sommes tr\u00e8s exp\u00e9riment\u00e9s dans la validation de technologies de pointe, y compris l&rsquo;imagerie num\u00e9rique visuelle multiplex (MVDI), le s\u00e9quen\u00e7age de nouvelle g\u00e9n\u00e9ration (NGS) et les biomarqueurs complexes en oncologie.<\/p>\n<p>La strat\u00e9gie r\u00e9glementaire chez MDx CRO est directement dirig\u00e9e par notre PDG, Carlos Galamba. En tant que leader reconnu dans le secteur des DIV, ancien responsable technique mondial et responsable clinique chez BSI (organisme notifi\u00e9), et conseiller ind\u00e9pendant aupr\u00e8s de la Commission europ\u00e9enne, Carlos apporte une connaissance interne in\u00e9gal\u00e9e pour garantir que votre programme CDx atteigne le march\u00e9 efficacement et en pleine conformit\u00e9. <\/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\":\"Comment une ORC DIV m\u00e8ne-t-elle des \u00e9tudes de performances cliniques ISO 20916 ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Nous d\u00e9finissons les crit\u00e8res d&rsquo;\u00e9valuation et la conception de l&rsquo;\u00e9tude, \u00e9laborons les protocoles et les eCRF, qualifions les sites, surveillons la conduite, g\u00e9rons les donn\u00e9es et les biostatistiques, et compilons les preuves cliniques pour le rapport d&rsquo;\u00e9valuation des performances. Notre approche s&rsquo;aligne sur l&rsquo;Annexe XIII\/XIV de l&rsquo;IVDR et les attentes des organismes notifi\u00e9s.\"}},{\"@type\":\"Question\",\"name\":\"Que fait une ORC DIV ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Une ORC DIV con\u00e7oit et ex\u00e9cute des activit\u00e9s de performances analytiques et cliniques, pr\u00e9pare la documentation technique et soutient les soumissions IVDR et FDA.  Chez MDx CRO, nous int\u00e9grons la r\u00e9glementation, la biostatistique, la gestion de site et la qualit\u00e9 pour fournir des preuves conformes \u00e0 la norme ISO 20916 pour le marquage CE et les approbations am\u00e9ricaines.\"}},{\"@type\":\"Question\",\"name\":\"Les \u00e9tudes cliniques sont-elles requises pour la conformit\u00e9 \u00e0 l'IVDR de l'UE ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Pas toujours. En vertu de l&rsquo;IVDR de l&rsquo;UE, les performances cliniques doivent \u00eatre d\u00e9montr\u00e9es par une ou plusieurs des sources suivantes : \\n\\n\u00c9tudes de performances cliniques (Annexe XIII et Annexe XIV),\\n\\n\\nLitt\u00e9rature scientifique pertinente pour l&rsquo;usage pr\u00e9vu du dispositif, ou\\n\\n\\nExp\u00e9rience publi\u00e9e issue de l&rsquo;utilisation diagnostique de routine.\\n\\nLes fabricants doivent planifier ces preuves dans le Plan d&rsquo;\u00e9valuation des performances (PEP) et les r\u00e9sumer dans le Rapport de performances cliniques (CPR) et le Rapport d&rsquo;\u00e9valuation des performances (PER). Bien que tous les DIV ne n\u00e9cessitent pas une nouvelle \u00e9tude clinique,   au moins une de ces sources doit \u00eatre disponible et suffisante pour \u00e9tayer les performances cliniques revendiqu\u00e9es.\"}},{\"@type\":\"Question\",\"name\":\"MDx peut-il soutenir les transitions LDT vers DIV ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Oui, nous aidons les laboratoires et les d\u00e9veloppeurs de tests \u00e0 convertir les LDT en DIV conformes avec un soutien sur la documentation, la validation et la s\u00e9lection de la voie d&rsquo;acc\u00e8s au march\u00e9.\"}},{\"@type\":\"Question\",\"name\":\"Combien de temps prend g\u00e9n\u00e9ralement le marquage CE ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"La plupart des clients atteignent la pr\u00e9paration au marquage CE en 6 \u00e0 18 mois, selon la classe de risque, la disponibilit\u00e9 des donn\u00e9es et la disponibilit\u00e9 de l&rsquo;organisme notifi\u00e9.\"}},{\"@type\":\"Question\",\"name\":\"O\u00f9 puis-je obtenir un soutien r\u00e9glementaire complet pour les programmes DIV-CDx ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Chez MDx CRO, nous fournissons un soutien r\u00e9glementaire et clinique complet et mondial, sp\u00e9cifiquement adapt\u00e9 aux diagnostics compagnons (CDx) et aux programmes de m\u00e9decine de pr\u00e9cision.\\nNaviguer dans les doubles complexit\u00e9s du cod\u00e9veloppement m\u00e9dicament-diagnostic exige une expertise sp\u00e9cialis\u00e9e. Notre \u00e9quipe r\u00e9glementaire est id\u00e9alement positionn\u00e9e pour combler cette lacune : \\nExperts d&rsquo;anciens organismes notifi\u00e9s : Notre \u00e9quipe comprend d&rsquo;anciens \u00e9valuateurs et experts techniques d&rsquo;organismes notifi\u00e9s qui comprennent exactement ce que les r\u00e9gulateurs europ\u00e9ens recherchent dans le cadre de l&rsquo;IVDR, minimisant ainsi les risques de soumission.\\nPort\u00e9e strat\u00e9gique mondiale (FDA et IVDR) : Nous g\u00e9rons l&rsquo;ensemble du parcours r\u00e9glementaire, du marquage CE europ\u00e9en aux soumissions CDx de la FDA (y compris les pr\u00e9-soumissions, les IDE et les PMA), garantissant que le calendrier de votre diagnostic s&rsquo;aligne parfaitement avec les jalons th\u00e9rapeutiques de votre partenaire pharmaceutique.\\nExpertise approfondie en MVDI et NGS : Nous sommes tr\u00e8s exp\u00e9riment\u00e9s dans la validation de technologies de pointe, y compris l&rsquo;imagerie num\u00e9rique visuelle multiplex (MVDI), le s\u00e9quen\u00e7age de nouvelle g\u00e9n\u00e9ration (NGS) et les biomarqueurs complexes en oncologie.\\nLa strat\u00e9gie r\u00e9glementaire chez MDx CRO est directement dirig\u00e9e par notre PDG, Carlos Galamba. En tant que leader reconnu dans le secteur des DIV, ancien responsable technique mondial et responsable clinique chez BSI (organisme notifi\u00e9), et conseiller ind\u00e9pendant aupr\u00e8s de la Commission europ\u00e9enne, Carlos apporte une connaissance interne in\u00e9gal\u00e9e pour garantir que votre programme CDx atteigne le march\u00e9 efficacement et en pleine conformit\u00e9.\"}}]}  <\/script>\n\n<section id=\"block_123fbd581a78bb36e173cbc755dc3c37\" 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\">Mettez votre DIV sur le march\u00e9, plus rapidement et en toute conformit\u00e9<\/h2>\n                \n                                    <div class=\"description wysiwyg\">\n                        <p>Que vous d\u00e9veloppiez un essai \u00e0 flux lat\u00e9ral, que vous vous pr\u00e9pariez au marquage CE ou que vous planifiiez une \u00e9tude clinique DIV, notre ORC DIV fournit les services complets dont vous avez besoin pour un succ\u00e8s mondial.<\/p>\n                    <\/div>\n                            <\/div>\n\n                            <div class=\"button-wrapper\">\n                                                                        <a href=\"https:\/\/mdxcro.com\/fr\/contact\/?utm_source=ind_end_to_end\" class=\"button button--tertiary\" target=\"\">\n                                R\u00e9server un appel de d\u00e9couverte                            <\/a>\n                                                            <\/div>\n                    <\/div>\n    <\/div>\n<\/section>\n","protected":false},"featured_media":0,"parent":0,"template":"","meta":{"_acf_changed":false},"class_list":["post-12100","sector","type-sector","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>Services d&#039;ORC DIV | Accompagnement complet IVDR et FDA | MDx CRO<\/title>\n<meta name=\"description\" content=\"Vous recherchez une ORC DIV ? MDx CRO r\u00e9alise des \u00e9tudes analytiques et cliniques compl\u00e8tes, l&#039;Annexe XIV de l&#039;IVDR, le marquage CE et les soumissions \u00e0 la FDA.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/mdxcro.com\/fr\/sectors\/ivd-de-bout-en-bout\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Services d&#039;ORC DIV | Accompagnement complet IVDR et FDA | MDx CRO\" \/>\n<meta property=\"og:description\" content=\"Vous recherchez une ORC DIV ? MDx CRO r\u00e9alise des \u00e9tudes analytiques et cliniques compl\u00e8tes, l&#039;Annexe XIV de l&#039;IVDR, le marquage CE et les soumissions \u00e0 la FDA.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/mdxcro.com\/fr\/sectors\/ivd-de-bout-en-bout\/\" \/>\n<meta property=\"og:site_name\" content=\"MDx CRO\" \/>\n<meta property=\"article:modified_time\" content=\"2026-07-22T10:06:14+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/mdxcro.com\\\/fr\\\/sectors\\\/ivd-de-bout-en-bout\\\/\",\"url\":\"https:\\\/\\\/mdxcro.com\\\/fr\\\/sectors\\\/ivd-de-bout-en-bout\\\/\",\"name\":\"Services d'ORC DIV | Accompagnement complet IVDR et FDA | MDx CRO\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/mdxcro.com\\\/fr\\\/#website\"},\"datePublished\":\"2025-07-29T14:17:18+00:00\",\"dateModified\":\"2026-07-22T10:06:14+00:00\",\"description\":\"Vous recherchez une ORC DIV ? MDx CRO r\u00e9alise des \u00e9tudes analytiques et cliniques compl\u00e8tes, l'Annexe XIV de l'IVDR, le marquage CE et les soumissions \u00e0 la FDA.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/mdxcro.com\\\/fr\\\/sectors\\\/ivd-de-bout-en-bout\\\/#breadcrumb\"},\"inLanguage\":\"fr-FR\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/mdxcro.com\\\/fr\\\/sectors\\\/ivd-de-bout-en-bout\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/mdxcro.com\\\/fr\\\/sectors\\\/ivd-de-bout-en-bout\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/mdxcro.com\\\/fr\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Services DIV de bout en bout\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/mdxcro.com\\\/fr\\\/#website\",\"url\":\"https:\\\/\\\/mdxcro.com\\\/fr\\\/\",\"name\":\"MDx CRO\",\"description\":\"MedTech &amp; IVD Clinical Research, Regulatory &amp; QA\",\"publisher\":{\"@id\":\"https:\\\/\\\/mdxcro.com\\\/fr\\\/#organization\"},\"alternateName\":\"MDx\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/mdxcro.com\\\/fr\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"fr-FR\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/mdxcro.com\\\/fr\\\/#organization\",\"name\":\"MDx CRO\",\"url\":\"https:\\\/\\\/mdxcro.com\\\/fr\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\\\/\\\/mdxcro.com\\\/fr\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/mdxcro.com\\\/wp-content\\\/uploads\\\/2025\\\/07\\\/MDX.svg\",\"contentUrl\":\"https:\\\/\\\/mdxcro.com\\\/wp-content\\\/uploads\\\/2025\\\/07\\\/MDX.svg\",\"width\":352,\"height\":114,\"caption\":\"MDx CRO\"},\"image\":{\"@id\":\"https:\\\/\\\/mdxcro.com\\\/fr\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.linkedin.com\\\/company\\\/medtech-ivd-cro\"]}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Services d'ORC DIV | Accompagnement complet IVDR et FDA | MDx CRO","description":"Vous recherchez une ORC DIV ? MDx CRO r\u00e9alise des \u00e9tudes analytiques et cliniques compl\u00e8tes, l'Annexe XIV de l'IVDR, le marquage CE et les soumissions \u00e0 la FDA.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/mdxcro.com\/fr\/sectors\/ivd-de-bout-en-bout\/","og_locale":"fr_FR","og_type":"article","og_title":"Services d'ORC DIV | Accompagnement complet IVDR et FDA | MDx CRO","og_description":"Vous recherchez une ORC DIV ? MDx CRO r\u00e9alise des \u00e9tudes analytiques et cliniques compl\u00e8tes, l'Annexe XIV de l'IVDR, le marquage CE et les soumissions \u00e0 la FDA.","og_url":"https:\/\/mdxcro.com\/fr\/sectors\/ivd-de-bout-en-bout\/","og_site_name":"MDx CRO","article_modified_time":"2026-07-22T10:06:14+00:00","twitter_card":"summary_large_image","schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/mdxcro.com\/fr\/sectors\/ivd-de-bout-en-bout\/","url":"https:\/\/mdxcro.com\/fr\/sectors\/ivd-de-bout-en-bout\/","name":"Services d'ORC DIV | Accompagnement complet IVDR et FDA | MDx CRO","isPartOf":{"@id":"https:\/\/mdxcro.com\/fr\/#website"},"datePublished":"2025-07-29T14:17:18+00:00","dateModified":"2026-07-22T10:06:14+00:00","description":"Vous recherchez une ORC DIV ? MDx CRO r\u00e9alise des \u00e9tudes analytiques et cliniques compl\u00e8tes, l'Annexe XIV de l'IVDR, le marquage CE et les soumissions \u00e0 la FDA.","breadcrumb":{"@id":"https:\/\/mdxcro.com\/fr\/sectors\/ivd-de-bout-en-bout\/#breadcrumb"},"inLanguage":"fr-FR","potentialAction":[{"@type":"ReadAction","target":["https:\/\/mdxcro.com\/fr\/sectors\/ivd-de-bout-en-bout\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/mdxcro.com\/fr\/sectors\/ivd-de-bout-en-bout\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/mdxcro.com\/fr\/"},{"@type":"ListItem","position":2,"name":"Services DIV de bout en bout"}]},{"@type":"WebSite","@id":"https:\/\/mdxcro.com\/fr\/#website","url":"https:\/\/mdxcro.com\/fr\/","name":"MDx CRO","description":"MedTech &amp; IVD Clinical Research, Regulatory &amp; QA","publisher":{"@id":"https:\/\/mdxcro.com\/fr\/#organization"},"alternateName":"MDx","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/mdxcro.com\/fr\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"fr-FR"},{"@type":"Organization","@id":"https:\/\/mdxcro.com\/fr\/#organization","name":"MDx CRO","url":"https:\/\/mdxcro.com\/fr\/","logo":{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/mdxcro.com\/fr\/#\/schema\/logo\/image\/","url":"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX.svg","contentUrl":"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX.svg","width":352,"height":114,"caption":"MDx CRO"},"image":{"@id":"https:\/\/mdxcro.com\/fr\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.linkedin.com\/company\/medtech-ivd-cro"]}]}},"_links":{"self":[{"href":"https:\/\/mdxcro.com\/fr\/wp-json\/wp\/v2\/sector\/12100","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mdxcro.com\/fr\/wp-json\/wp\/v2\/sector"}],"about":[{"href":"https:\/\/mdxcro.com\/fr\/wp-json\/wp\/v2\/types\/sector"}],"wp:attachment":[{"href":"https:\/\/mdxcro.com\/fr\/wp-json\/wp\/v2\/media?parent=12100"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}