{"id":12042,"date":"2025-07-30T07:26:59","date_gmt":"2025-07-30T07:26:59","guid":{"rendered":"https:\/\/mdxcro.com\/services\/etudes-analytiques-ivd\/"},"modified":"2026-07-22T10:08:04","modified_gmt":"2026-07-22T10:08:04","slug":"etudes-analytiques-ivd","status":"publish","type":"service","link":"https:\/\/mdxcro.com\/fr\/services\/etudes-analytiques-ivd\/","title":{"rendered":"\u00c9tudes analytiques IVD"},"content":{"rendered":"\n<section id=\"block_d417e52e19842b638303360b80bd762a\" 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\">Une validation analytique de DIV qui acc\u00e9l\u00e8re l\u2019approbation mondiale<\/h1>\n            \n                            <div class=\"description\"><p><span style=\"font-weight: 400;\">\u00c9tudes de performance analytique dirig\u00e9es par des experts pour la conformit\u00e9 IVDR, FDA et CLSI \u2014 couvrant la sensibilit\u00e9, la sp\u00e9cificit\u00e9, la stabilit\u00e9 et les APR. Acc\u00e9dez plus rapidement au march\u00e9 avec MDx CRO. <\/span><\/p>\n<\/div>\n            \n                            <div class=\"button-wrapper\">\n                                            <a href=\"https:\/\/mdxcro.com\/fr\/contact\/?utm_source=ivd_analytical_studies\" class=\"button bouton--par d\u00e9faut\" target=\"_self\">\n                            R\u00e9server une consultation                        <\/a>\n                                            <a href=\"https:\/\/mdxcro.com\/a-cros-guide-to-ivd-analytical-validation-best-practices-common-pitfalls\/\" class=\"button bouton--secondaire\" target=\"_self\">\n                            Explorez notre guide de validation analytique de DIV                        <\/a>\n                                    <\/div>\n                            <\/div>\n            <\/div>\n<\/section>\n\n<section id=\"block_f1332485f647a908b73c1b938f3203bc\" class=\"text-image\" style=\"margin-top: 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\">Pourquoi la <span class=\"blue-highlight\"> validation analytique <\/span> est essentielle<\/h2><div class=\"description wysiwyg\"><p><span style=\"font-weight: 400\">La validation analytique est le fondement des preuves cliniques et de l\u2019approbation r\u00e9glementaire des DIV. Qu\u2019il s\u2019agisse du lancement d\u2019un nouvel essai de diagnostic ou de la transition d\u2019un produit existant vers l\u2019IVDR, des donn\u00e9es de performance analytique robustes sont essentielles pour d\u00e9montrer la fiabilit\u00e9, l\u2019exactitude et la s\u00e9curit\u00e9 de l\u2019essai. Chez MDx CRO, nous r\u00e9alisons des \u00e9tudes analytiques qui r\u00e9pondent aux normes mondiales les plus strictes, garantissant que vos revendications de performance sont \u00e9tay\u00e9es, que vos soumissions r\u00e9ussissent et que vos d\u00e9lais sont respect\u00e9s.  <\/span><\/p>\n<ul>\n<li style=\"font-weight: 400\"><b>Champ d\u2019application complet :<\/b><span style=\"font-weight: 400\"> \u00e9tudes de sensibilit\u00e9 analytique, sp\u00e9cificit\u00e9, exactitude, pr\u00e9cision, LoD\/LoQ, lin\u00e9arit\u00e9 et stabilit\u00e9.<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Alignement r\u00e9glementaire :<\/b><span style=\"font-weight: 400\"> Annexe I de l\u2019IVDR, FDA 510(k)\/PMA et directives CLSI (EP05, EP17, EP25, etc.).<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Laboratoires partenaires qualifi\u00e9s ISO 15189<\/b><span style=\"font-weight: 400\"> et une exp\u00e9rience confirm\u00e9e aupr\u00e8s des organismes notifi\u00e9s et de la FDA.<\/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\/07\/analytical-validation.jpg\" alt=\"Innovative scientist working in a modern laboratory focused on advancing medtech solutions for healthcare.\"  \/><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n<section id=\"block_7a00934f9b580866d79fa9c5074e6c19\" class=\"flip-cards flip-cards--three-columns \" style=\"padding-bottom: var(--wp--preset--spacing--regular); \">\n            <div class=\"container\">\n        <div class=\"content\">\n                            <h3 class=\"subtitle\">Conception et ex\u00e9cution d\u2019\u00e9tudes analytiques compl\u00e8tes<\/h3>\n            \n                            <h2 class=\"title\">MDx CRO assure la validation analytique de bout en bout pour les DIV<\/h2>\n            \n            \n                    <\/div>\n\n                    <div class=\"grid\">\n                                    <div class=\"card card--background-white\"\n                                                  >\n                        \n                                                    <div class=\"circle circle--no-bg\">\n                                <img decoding=\"async\" class=\"icon\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX-Icon-Black-61.png\" alt=\"\" \/>\n                                <img decoding=\"async\" class=\"icon icon--hover\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX-Icon-White-61.png\" alt=\"\" \/>\n                            <\/div>\n                        \n                        <div class=\"front\">Planification et strat\u00e9gie<\/div>\n                        <div class=\"back\"><ul>\n<li>Feuille de route r\u00e9glementaire (IVDR\/FDA)<\/li>\n<li>Plan de performance analytique<\/li>\n<li>D\u00e9veloppement de protocoles<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-blue\"\n                                                  >\n                        \n                                                    <div class=\"circle circle--no-bg\">\n                                <img decoding=\"async\" class=\"icon\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX-Icon-White-2.png\" alt=\"\" \/>\n                                <img decoding=\"async\" class=\"icon icon--hover\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX-Icon-White-2.png\" alt=\"\" \/>\n                            <\/div>\n                        \n                        <div class=\"front\">Validation de l\u2019essai<\/div>\n                        <div class=\"back\"><ul>\n<li>Validation des m\u00e9thodes analytiques<\/li>\n<li>Conception d\u2019\u00e9tudes conformes au CLSI<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-black\"\n                                                  >\n                        \n                                                    <div class=\"circle circle--no-bg\">\n                                <img decoding=\"async\" class=\"icon\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX-Icon-White-6.png\" alt=\"\" \/>\n                                <img decoding=\"async\" class=\"icon icon--hover\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX-Icon-Black-6-1.png\" alt=\"\" \/>\n                            <\/div>\n                        \n                        <div class=\"front\">Ex\u00e9cution de l\u2019\u00e9tude<\/div>\n                        <div class=\"back\"><ul>\n<li>Qualification des sites et laboratoires, gestion de projet<\/li>\n<li>Suivi,<\/li>\n<li>Collecte de donn\u00e9es<\/li>\n<li>Pr\u00e9paration aux audits<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-blue\"\n                                                  >\n                        \n                                                    <div class=\"circle circle--no-bg\">\n                                <img decoding=\"async\" class=\"icon\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX-Icon-White-46.png\" alt=\"\" \/>\n                                <img decoding=\"async\" class=\"icon icon--hover\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX-Icon-White-46.png\" alt=\"\" \/>\n                            <\/div>\n                        \n                        <div class=\"front\">Rapports et soumission<\/div>\n                        <div class=\"back\"><ul>\n<li>Rapport de performance analytique (APR)<\/li>\n<li>Dossiers de preuves IVDR<\/li>\n<li>Soutien aux Q-submissions de la FDA<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-white\"\n                                                  >\n                        \n                                                    <div class=\"circle circle--no-bg\">\n                                <img decoding=\"async\" class=\"icon\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX-Icon-Black-4-1.png\" alt=\"\" \/>\n                                <img decoding=\"async\" class=\"icon icon--hover\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX-Icon-White-4.png\" alt=\"\" \/>\n                            <\/div>\n                        \n                        <div class=\"front\">Technologies prises en charge<\/div>\n                        <div class=\"back\"><ul>\n<li>PCR<\/li>\n<li>NGS<\/li>\n<li>IHC, immunoessais<\/li>\n<li>Multiplex<\/li>\n<li>Flux lat\u00e9ral<\/li>\n<li>SaMD<\/li>\n<li>et plus encore<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-blue\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Formation et transfert de connaissances<\/div>\n                        <div class=\"back\"><ul>\n<li>  Processus de validation analytique<\/li>\n<li>Exigences de preuves IVDR<\/li>\n<li>Transfert de connaissances pour des capacit\u00e9s internes durables<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                            <\/div>\n        \n            <\/div>\n<\/section>\n<section id=\"block_9e49b32e2c0dc49b281f667cbd1c2bc8\" class=\"content-columns content-columns--four-columns content-columns--background-white\" style=\"padding-top: var(--wp--preset--spacing--regular); padding-bottom: var(--wp--preset--spacing--regular); \">\n        <div class=\"container\">\n                    <div class=\"content\">\n                                    <h2 class=\"title\">Ce que nous livrons<\/h2>\n                                            <\/div>\n        \n                    <div class=\"grid\">\n                                                        <div class=\"card card--background-white-frost\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Protocoles de validation d\u2019essais<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Sensibilit\u00e9 et sp\u00e9cificit\u00e9 analytiques<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">\u00c9tudes d\u2019exactitude et de pr\u00e9cision<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Limite de d\u00e9tection (LoD) \/ limite de quantification (LoQ) \/ lin\u00e9arit\u00e9<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Interf\u00e9rence et r\u00e9activit\u00e9 crois\u00e9e<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Reproductibilit\u00e9 et r\u00e9p\u00e9tabilit\u00e9<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Soutien \u00e0 la pr\u00e9-qualification de l\u2019OMS<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white-frost\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Conception d\u2019\u00e9tudes de stabilit\u00e9<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">\u00c9tudes de stabilit\u00e9 en temps r\u00e9el et acc\u00e9l\u00e9r\u00e9es<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">D\u00e9veloppement de protocoles (CLSI EP25)<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Analyse des donn\u00e9es et rapports<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white-frost\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Documentation et rapports<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Protocoles de validation analytique<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Rapports de performance analytique (APR)<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Dossiers de preuves conformes \u00e0 l\u2019IVDR<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Documentation pour Q-submission de la FDA<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white-frost\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Types d\u2019essais pris en charge<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Diagnostics mol\u00e9culaires (PCR, qPCR, NGS)<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Immunoessais et plateformes multiplex<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Kits de diagnostic bas\u00e9s sur l\u2019IHC<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Diagnostics bas\u00e9s sur des logiciels (SaMD)<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Tests \u00e0 flux lat\u00e9ral et de diagnostic imm\u00e9diat<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                <\/div>\n                  \n          \n\n                    <div class=\"button-wrapper\">\n                                    <a href=\"https:\/\/mdxcro.com\/fr\/domaines-therapeutiques\/\" class=\"button button--quaternary\" target=\"_self\">\n                        Explorer tous les domaines th\u00e9rapeutiques                    <\/a>\n                            <\/div>\n            <\/div>\n<\/section>\n\n<section id=\"block_2fe1da96f3beab1814542de967151337\" class=\"text-image text-image--background-frost-white text-image--reduced-spacing\" style=\"padding-top: var(--wp--preset--spacing--medium); padding-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\">Alignement r\u00e9glementaire<\/h2><div class=\"description wysiwyg\"><p><span style=\"font-weight: 400\">Vos \u00e9tudes analytiques sont adapt\u00e9es \u00e0 toutes les principales exigences internationales :<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400\"><b>IVDR Annexe I, Chapitre II, Partie A<\/b><span style=\"font-weight: 400\"> \u2013 Exigences de performance analytique<\/span><\/li>\n<li style=\"font-weight: 400\"><b>FDA 510(k), De Novo, PMA<\/b><span style=\"font-weight: 400\"> \u2013 Validation analytique et g\u00e9n\u00e9ration de preuves<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Directives CLSI<\/b><span style=\"font-weight: 400\"> \u2013 EP05, EP07, EP17, EP25, et plus encore<\/span><\/li>\n<li style=\"font-weight: 400\"><b>SMQ ISO 13485<\/b><span style=\"font-weight: 400\"> et <\/span><b>GSPR<\/b><span style=\"font-weight: 400\"> (UE)<\/span><\/li>\n<li style=\"font-weight: 400\"><b>ISO 15189<\/b><span style=\"font-weight: 400\"> normes de laboratoire<\/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\/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<section class=\"table\"><div class=\"container\"><div class=\"headline\">Pourquoi choisir MDx CRO ?<\/div><div class=\"table-wrapper\"><div class=\"feature-column-wrapper\"><table class=\"feature-table\"><thead><tr><th class=\"feature-column\">Capacit\u00e9<\/th><\/tr><\/thead><tbody><tr><td class=\"feature-cell\"><strong>Validation des m\u00e9thodes analytiques<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Expertise IVDR et FDA<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Conformit\u00e9 aux directives CLSI<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>D\u00e9veloppement d\u2019APR<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Expertise en essais<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Conception d\u2019\u00e9tudes de stabilit\u00e9<\/strong><\/td><\/tr><\/tbody><\/table><\/div><div class=\"scrollable-columns-wrapper\"><table class=\"comparison-table\"><thead><tr><th class=\"column highlight\">L\u2019avantage MDx CRO<\/th><th class=\"column\">CRO typiques<\/th><\/tr><\/thead><tbody><tr><td class=\"cell highlight\">D\u00e9velopp\u00e9s en interne, protocoles sur mesure<\/td><td class=\"cell\">Souvent g\u00e9n\u00e9riques<\/td><\/tr><tr><td class=\"cell highlight\">Exp\u00e9rience confirm\u00e9e, la plupart des technologies<\/td><td class=\"cell\">Limit\u00e9e<\/td><\/tr><tr><td class=\"cell highlight\">Alignement FDA et UE<\/td><td class=\"cell\">Partiel<\/td><\/tr><tr><td class=\"cell highlight\">Soutien complet, formatage IVDR<\/td><td class=\"cell\">Rarement propos\u00e9s<\/td><\/tr><tr><td class=\"cell highlight\">PCR, NGS, IHC, SaMD, immunoessais, flux lat\u00e9ral, etc.<\/td><td class=\"cell\">Limit\u00e9 par la technologie<\/td><\/tr><tr><td class=\"cell highlight\">Temps r\u00e9el et acc\u00e9l\u00e9r\u00e9, soutien complet<\/td><td class=\"cell\">Rarement propos\u00e9s<\/td><\/tr><\/tbody><\/table><\/div><\/div><\/div><\/section>\n<section id=\"block_a02309e8d7a20a436f3f131e71dcc2fc\" class=\"text-image text-image--background-frost-white\" style=\"padding-top: var(--wp--preset--spacing--medium); padding-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\">Des r\u00e9sultats qui comptent<\/h2><div class=\"description wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><b>Taux de r\u00e9ussite de 100 %<\/b><span style=\"font-weight: 400\"> : Aucune observation majeure des organismes notifi\u00e9s sur la conception des \u00e9tudes analytiques<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Plus de 40 projets<\/b><span style=\"font-weight: 400\"> : \u00c9tudes de performance analytique pour DIV, CDx et diagnostics num\u00e9riques<\/span><\/li>\n<\/ul>\n<p><b>Approuv\u00e9 par les 10 plus grands fabricants de DIV<\/b><span style=\"font-weight: 400\">, ainsi que par des entreprises de diagnostic en phase de d\u00e9marrage ou de taille moyenne<\/span><\/p>\n<\/div><\/div><\/div>                            <div class=\"column column--image\"><img decoding=\"async\" class=\"image\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/yaiza-hugo-scaled.jpg\" alt=\"Innovative MedTech collaboration, professionals discussing medical technology advancements, representing MDX&#039;s role in accelerating medical innovation and healthcare solutions.\"  \/><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n<section id=\"block_5ce9f010001e8493c26db41f7d2ff3e5\" class=\"testimonials\" style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/testimonials-bg.jpg&#039;);\">\n        <div class=\"testimonials--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\">T\u00e9moignages clients<\/div>\n        \n                    <div class=\"slider\">\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">\u00ab\u00a0MDx\u2019s analytical validation expertise enabled us to secure IVDR approval with zero major findings. Their tailored protocols and responsive team made all the difference.\u00a0\u00bb<\/p>\n                                                                            <p class=\"author\">\n                                Regulatory Affairs Director, Global IVD Manufacturer                                        \n                            <\/p>\n                                            <\/div>\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">\u00ab\u00a0As a US-based diagnostics company, MDx CRO was our bridge to European IVDR compliance. Their analytical study design team and APR support were world-class.\u00a0\u00bb<\/p>\n                                                                            <p class=\"author\">\n                                VP, Clinical Development, Molecular Diagnostics SME                                        \n                            <\/p>\n                                            <\/div>\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">\u00ab\u00a0MDx helped us navigate analytical validation under very tight timelines. Their team was hands-on, pragmatic, and always available when issues came up.\u00a0\u00bb<\/p>\n                                                                            <p class=\"author\">\n                                Director of Clinical Operations                                                                <br>\n                                European IVD Company                                        \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_6d21f1bbdb3158ee883e4b214eda381c\" 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\">Quelle est la diff\u00e9rence entre la validation analytique et la validation clinique ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">La validation analytique confirme qu\u2019un DIV mesure l\u2019analyte d\u2019int\u00e9r\u00eat de mani\u00e8re pr\u00e9cise, fiable et coh\u00e9rente (ex. : sensibilit\u00e9, sp\u00e9cificit\u00e9, pr\u00e9cision). La validation clinique \u00e9value la capacit\u00e9 du test \u00e0 identifier une condition clinique dans la population cible. Les deux sont requises pour les soumissions IVDR et FDA.  <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">MDx peut-il aider \u00e0 la cr\u00e9ation d\u2019APR et de rapports de performance analytique IVDR ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Oui. Nous assurons le d\u00e9veloppement complet de l\u2019APR, y compris l\u2019analyse statistique, la r\u00e9daction du r\u00e9sum\u00e9 et le formatage selon les exigences de l\u2019IVDR et de la FDA. <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Prenez-vous en charge la documentation conforme au CLSI ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Absolument. Nos protocoles et rapports sont align\u00e9s sur les normes CLSI (EP05, EP17, EP25, etc.), garantissant une acceptation r\u00e9glementaire mondiale. <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Quels types de technologies prenez-vous en charge ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Nous couvrons la PCR, le NGS, les immunoessais, l\u2019IHC, le multiplex, le flux lat\u00e9ral, le SaMD, et plus encore.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">En combien de temps une \u00e9tude de validation analytique peut-elle \u00eatre r\u00e9alis\u00e9e ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Les d\u00e9lais d\u00e9pendent de la complexit\u00e9 de l\u2019essai et de la disponibilit\u00e9 des \u00e9chantillons, mais la plupart des \u00e9tudes sont achev\u00e9es en 2 \u00e0 6 mois gr\u00e2ce \u00e0 la gestion de projet de MDx CRO.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                      <\/ul>\n              <\/div>\n    <\/div>\n  <\/div>\n<\/section>\n\n  <script type=\"application\/ld+json\">\n    {\"@context\":\"https:\/\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"Quelle est la diff\u00e9rence entre la validation analytique et la validation clinique ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"La validation analytique confirme qu\u2019un DIV mesure l\u2019analyte d\u2019int\u00e9r\u00eat de mani\u00e8re pr\u00e9cise, fiable et coh\u00e9rente (ex. : sensibilit\u00e9, sp\u00e9cificit\u00e9, pr\u00e9cision). 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