{"id":1275,"date":"2022-02-08T13:49:15","date_gmt":"2022-02-08T12:49:15","guid":{"rendered":"https:\/\/www.icta.fr\/?post_type=domaineexpertises&#038;p=1275"},"modified":"2023-07-07T09:12:09","modified_gmt":"2023-07-07T07:12:09","slug":"dispositif-medical","status":"publish","type":"domaineexpertises","link":"https:\/\/www.icta.fr\/fr\/expertises\/dispositif-medical\/","title":{"rendered":"Dispositif m\u00e9dical"},"content":{"rendered":"\n<h2 class=\"wp-block-heading is-style-grostitrebleucentre custom-bottommargin\" style=\"margin-bottom:10px\">DE LA CONCEPTION A LA COMMERCIALISATION DE<br> NOUVEAU DISPOSITIF M\u00c9DICAL (DM OU DM DIV),<br> LE PARCOURS PEUT \u00caTRE FLOU ET COMPLEXE<\/h2>\n\n\n\n<p class=\"is-style-soustitrebleucentre2 wp-block-paragraph\">Les r\u00e9glementations et les exigences varient selon les pays, le niveau de risque, les caract\u00e9ristiques du produit et son utilisation.<\/p>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<section class=\"wp-block-uagb-section uagb-section__wrap uagb-section__background-undefined uagb-block-4eb7836e\"><div class=\"uagb-section__overlay\"><\/div><div class=\"uagb-section__inner-wrap\"><div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img decoding=\"async\" width=\"573\" height=\"343\" src=\"https:\/\/www.icta.fr\/wp-content\/uploads\/FR-WEB-Medical-Device-Schema-1.png\" alt=\"Dispositif medical\" class=\"wp-image-5773\" srcset=\"https:\/\/www.icta.fr\/wp-content\/uploads\/FR-WEB-Medical-Device-Schema-1.png 573w, https:\/\/www.icta.fr\/wp-content\/uploads\/FR-WEB-Medical-Device-Schema-1-300x180.png 300w, https:\/\/www.icta.fr\/wp-content\/uploads\/FR-WEB-Medical-Device-Schema-1-240x145.png 240w\" sizes=\"(max-width: 573px) 100vw, 573px\" \/><\/figure>\n<\/div><\/div><\/section>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<section class=\"wp-block-uagb-section uagb-section__wrap uagb-section__background-undefined uagb-block-58de2cef\"><div class=\"uagb-section__overlay\"><\/div><div class=\"uagb-section__inner-wrap\">\n<div class=\"wp-block-columns is-style-default is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" width=\"1024\" height=\"600\" src=\"https:\/\/www.icta.fr\/wp-content\/uploads\/15_IMG_02-1024x600.jpg\" alt=\"Icta experience et \u00e9quipe\" class=\"wp-image-3440\" srcset=\"https:\/\/www.icta.fr\/wp-content\/uploads\/15_IMG_02-1024x600.jpg 1024w, https:\/\/www.icta.fr\/wp-content\/uploads\/15_IMG_02-300x176.jpg 300w, https:\/\/www.icta.fr\/wp-content\/uploads\/15_IMG_02-768x450.jpg 768w, https:\/\/www.icta.fr\/wp-content\/uploads\/15_IMG_02.jpg 1030w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h3 class=\"wp-block-heading is-style-soustitrebleugauche mt-0\">Dot\u00e9e d&#8217;une vaste exp\u00e9rience et culture dans tous les types de dispositifs m\u00e9dicaux, notre \u00e9quipe d\u2019experts DM comprend&nbsp;:<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>des chefs de projet<\/li>\n\n\n\n<li>des attach\u00e9s de recherche clinique<\/li>\n\n\n\n<li>des data managers<\/li>\n\n\n\n<li>des biostatisticiens<\/li>\n\n\n\n<li>des experts en r\u00e9glementation et en assurance qualit\u00e9<\/li>\n\n\n\n<li>des r\u00e9dacteurs m\u00e9dicaux<br><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading is-style-soustitrebleugauche mt-0\"><br>Nos experts peuvent vous accompagner<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>dans la conception, la mise en \u0153uvre et la gestion de tout ou partie de votre plan d\u2019investigation clinique (\u00e9tude pilote\/preuve de concept, \u00e9tude confirmatoire, \u00e9tude PMCF\/SCAC &#8220;suivi clinique apr\u00e8s commercialisation&#8221;),<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>quel que soit le type de dispositif m\u00e9dical (DM, DMDIV, dispositif combin\u00e9 (DM + m\u00e9dicament), DM connect\u00e9, logiciel en tant que DM),<\/li>\n\n\n\n<li>que votre objectif soit d\u2019\u00e9tayer une soumission r\u00e9glementaire avant la mise sur le march\u00e9 (c.-\u00e0-d. un dossier de marquage CE par un Organisme Notifi\u00e9), d\u2019obtenir le remboursement du produit ou de surveiller l&#8217;utilisation du produit apr\u00e8s sa mise sur le march\u00e9.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div><\/section>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<section class=\"wp-block-uagb-section uagb-section__wrap uagb-section__background-color uagb-block-a398f345 is-style-greysectionseparate separatewhite\"><div class=\"uagb-section__overlay\"><\/div><div class=\"uagb-section__inner-wrap\">\n<div style=\"height:60px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full\"><img decoding=\"async\" width=\"922\" height=\"304\" src=\"https:\/\/www.icta.fr\/wp-content\/uploads\/FR-WEB-Frise_Market.png\" alt=\"Sch\u00e9ma \u00e9tudes interventionnelles icta\n\" class=\"wp-image-5769\" srcset=\"https:\/\/www.icta.fr\/wp-content\/uploads\/FR-WEB-Frise_Market.png 922w, https:\/\/www.icta.fr\/wp-content\/uploads\/FR-WEB-Frise_Market-300x99.png 300w, https:\/\/www.icta.fr\/wp-content\/uploads\/FR-WEB-Frise_Market-768x253.png 768w\" sizes=\"(max-width: 922px) 100vw, 922px\" \/><\/figure>\n<\/div>\n\n\n<div style=\"height:60px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns is-style-default is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\">\n<h3 class=\"wp-block-heading is-style-titrefondvert\">\u00c9TUDES interventionnelles<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Etudes pilotes<\/li>\n\n\n\n<li>Etudes confirmatoires (Pre- et Post-AMM)<\/li>\n\n\n\n<li>Etudes PASS (Innovation Post-Authorisation Safety Studies)<\/li>\n<\/ul>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<h3 class=\"wp-block-heading is-style-titrefondbleu\">\u00c9TUDES NON INTERVENTIONNELLES<\/h3>\n\n\n\n<div class=\"wp-block-columns is-style-default is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<ul class=\"wp-block-list\">\n<li>\u00c9tudes de suivi clinique apr\u00e8s commercialisation (SCAC\/PMCF)<\/li>\n\n\n\n<li>Registres apr\u00e8s la commercialisation<\/li>\n\n\n\n<li>\u00c9valuations \u00e9conomiques de la sant\u00e9<\/li>\n\n\n\n<li>Rapports de mat\u00e9riovigilance<\/li>\n<\/ul>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<ul class=\"wp-block-list\">\n<li>\u00c9tudes centr\u00e9es sur le patient<\/li>\n\n\n\n<li>Base de donn\u00e9es des syst\u00e8mes de sant\u00e9<\/li>\n\n\n\n<li>Analyses (SNDS\u2026)<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading is-style-grostitrebleucentre\">NOS SERVICES<\/h2>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns is-style-default is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h3 class=\"wp-block-heading is-style-titrefondvert\">conseil en D\u00c9VELOPPEMENT CLINIQUE DU DM<\/h3>\n\n\n\n<div class=\"wp-block-columns is-style-default is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<ul class=\"wp-block-list\">\n<li>Revue de la litt\u00e9rature<\/li>\n\n\n\n<li>Strat\u00e9gie clinique et r\u00e9glementaire<\/li>\n\n\n\n<li>Conception et validation des investigations<\/li>\n<\/ul>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<ul class=\"wp-block-list\">\n<li>Classification des produits et des risques<\/li>\n\n\n\n<li>\u00c9tudes de faisabilit\u00e9 pr\u00e9coces<\/li>\n\n\n\n<li>Gestion des risques<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h3 class=\"wp-block-heading is-style-titrefondbleu\">INVESTIGATIONS AVANT\/APR\u00c8S LA MISE SUR LE MARCH\u00c9<\/h3>\n\n\n\n<div class=\"wp-block-columns is-style-default is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<ul class=\"wp-block-list\">\n<li>Conception et r\u00e9daction m\u00e9dicale<\/li>\n\n\n\n<li>Soumissions r\u00e9glementaires<\/li>\n\n\n\n<li>Suivi clinique \n\n\n\n\n\n\n\n<\/li>\n\n\n\n<li>Gestion des investigations cliniques  \n\n\n\n\n\n\n\n<\/li>\n<\/ul>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<ul class=\"wp-block-list\">\n<li>Biom\u00e9trie et sciences des donn\u00e9es<\/li>\n\n\n\n<li>Mat\u00e9riovigilance et PSUR<\/li>\n\n\n\n<li>Rapports d&#8217;\u00e9tudes cliniques<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div><\/section>\n\n\n\n<div style=\"height:60px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<section class=\"wp-block-uagb-section uagb-section__wrap uagb-section__background-undefined uagb-block-23e70513\"><div class=\"uagb-section__overlay\"><\/div><div class=\"uagb-section__inner-wrap\">\n<p class=\"is-style-soustitrebleucentre2 wp-block-paragraph\">Notre exp\u00e9rience couvre l\u2019\u00e9valuation des dispositifs m\u00e9dicaux, DMDIV, DM &#8220;combin\u00e9&#8221;, et DM &#8220;logiciel&#8221; utilis\u00e9s pour de nombreuses indications dans un large \u00e9ventail de domaines th\u00e9rapeutiques<\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading is-style-grostitrebleucentre ext-max-width ext-maxw-align-center\" style=\"max-width:500px\">L&#8217;\u00c9QUIPE ICTA SP\u00c9CIALIS\u00c9E DANS LA CONCEPTION ET GESTION D\u2019\u00c9TUDES EN VIE R\u00c9ELLE PEUT \u00c9GALEMENT VOUS AIDER \u00c0 CONCEVOIR :<\/h2>\n\n\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns is-style-default is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large\"><img decoding=\"async\" width=\"49\" height=\"49\" src=\"https:\/\/www.icta.fr\/wp-content\/uploads\/15_Icon-feather-arrow-down-circle.svg\" alt=\"medical device arrow\" class=\"wp-image-3454\"\/><\/figure>\n<\/div>\n\n\n<h3 class=\"wp-block-heading is-style-soustitrebleucentre ext-max-width ext-maxw-align-center\" style=\"max-width:300px\">DES \u00c9TUDES AVANT COMMERCIALISATION<br> pour vous permettre de mieux appr\u00e9hender l&#8217;utilisation du dispositif m\u00e9dical dans un cadre clinique plus large et prendre les bonnes d\u00e9cisions r\u00e9glementaires<\/h3>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large\"><img decoding=\"async\" width=\"49\" height=\"49\" src=\"https:\/\/www.icta.fr\/wp-content\/uploads\/15_Icon-feather-arrow-down-circle.svg\" alt=\"medical device arrow\" class=\"wp-image-3454\"\/><\/figure>\n<\/div>\n\n\n<h3 class=\"wp-block-heading is-style-soustitrebleucentre ext-max-width ext-maxw-align-center\" style=\"max-width:300px\">DES \u00c9TUDES APR\u00c8S COMMERCIALISATION<br> pour l\u2019extension du marquage CE et assurer la surveillance apr\u00e8s commercialisation (\u00e9tudes en vie r\u00e9elle).<\/h3>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large\"><img decoding=\"async\" width=\"87\" height=\"87\" src=\"https:\/\/www.icta.fr\/wp-content\/uploads\/15_Icon2-feather-arrow-down-circle.svg\" alt=\"medical device arrow\" class=\"wp-image-3455\"\/><\/figure>\n<\/div>\n\n\n<h3 class=\"wp-block-heading is-style-soustitrebleucentre ext-max-width ext-maxw-align-center\" style=\"max-width:540px\">Quel que soit le stade de d\u00e9veloppement de votre dispositif m\u00e9dical, l&#8217;\u00e9quipe ICTA vous apporte sa vision, ses comp\u00e9tences et son savoir-faire pour vous aider \u00e0 :<\/h3>\n\n\n\n<div style=\"height:44px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns is-style-default is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large\"><img decoding=\"async\" width=\"56\" height=\"57\" src=\"https:\/\/www.icta.fr\/wp-content\/uploads\/15_Icon01.svg\" alt=\"Mieux comprendre le march\u00e9 et identifier la bonne strat\u00e9gie pour votre dispositif m\u00e9dical\" class=\"wp-image-3458\"\/><\/figure>\n<\/div>\n\n\n<p class=\"has-text-align-center ext-max-width ext-maxw-align-center wp-block-paragraph\" style=\"max-width:250px\">Mieux comprendre le march\u00e9 et identifier la bonne strat\u00e9gie pour votre dispositif m\u00e9dical<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large\"><img decoding=\"async\" width=\"55\" height=\"55\" src=\"https:\/\/www.icta.fr\/wp-content\/uploads\/15_Icon02.svg\" alt=\"Mettre en place un plan d'investigation global pertinent pour votre dispositif m\u00e9dical\" class=\"wp-image-3459\"\/><\/figure>\n<\/div>\n\n\n<p class=\"has-text-align-center ext-max-width ext-maxw-align-center wp-block-paragraph\" style=\"max-width:250px\">Mettre en place un plan d&#8217;investigation global pertinent pour votre dispositif m\u00e9dical<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large\"><img decoding=\"async\" width=\"59\" height=\"55\" src=\"https:\/\/www.icta.fr\/wp-content\/uploads\/15_Icon03.svg\" alt=\"\u00c9valuer la s\u00e9curit\u00e9 et les performances de votre dispositif m\u00e9dical, et collecter les donn\u00e9es n\u00e9cessaires \u00e0 son marquage CE\" class=\"wp-image-3460\"\/><\/figure>\n<\/div>\n\n\n<p class=\"has-text-align-center ext-max-width ext-maxw-align-center wp-block-paragraph\">\u00c9valuer la s\u00e9curit\u00e9 et les performances de votre dispositif m\u00e9dical, et collecter les donn\u00e9es n\u00e9cessaires \u00e0 son marquage CE<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large\"><img decoding=\"async\" width=\"61\" height=\"50\" src=\"https:\/\/www.icta.fr\/wp-content\/uploads\/15_Icon04.svg\" alt=\"R\u00e9duire les risques et assurer la conformit\u00e9 de votre dispositif m\u00e9dical avec les r\u00e9glementations et les exigences ISO.\" class=\"wp-image-3461\"\/><\/figure>\n<\/div>\n\n\n<p class=\"has-text-align-center ext-max-width ext-maxw-align-center wp-block-paragraph\" style=\"max-width:250px\">R\u00e9duire les risques et assurer la conformit\u00e9 de votre dispositif m\u00e9dical avec les r\u00e9glementations et les exigences ISO.<\/p>\n<\/div>\n<\/div>\n<\/div><\/section>\n\n\n\n<div style=\"height:60px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<section class=\"wp-block-uagb-section uagb-section__wrap uagb-section__background-color uagb-block-17b00dd7 is-style-greysectionseparate separatewhite\"><div class=\"uagb-section__overlay\"><\/div><div class=\"uagb-section__inner-wrap\">\n<h2 class=\"wp-block-heading has-text-align-center\">AUTRES DOMAINES D&#8217;EXPERTISE<\/h2>\n\n\n\n        <div class=\"wp-block-getwid-post-carousel custom-post-type-domaineexpertises servicelist has-slides-gap-normal is-carousel has-arrows-outside has-dots-none\">\n            <div data-slider-option=\"{&quot;sliderSlidesToShowDesktop&quot;:&quot;3&quot;,&quot;getwid_slidesToShowLaptop&quot;:&quot;1&quot;,&quot;getwid_slidesToShowTablet&quot;:&quot;1&quot;,&quot;getwid_slidesToShowMobile&quot;:&quot;1&quot;,&quot;getwid_autoplay_speed&quot;:6000,&quot;getwid_animation_speed&quot;:800,&quot;getwid_slidesToScroll&quot;:&quot;1&quot;,&quot;getwid_autoplay&quot;:false,&quot;getwid_pause_on_hover&quot;:false,&quot;getwid_infinite&quot;:true,&quot;getwid_center_mode&quot;:false,&quot;getwid_arrows&quot;:&quot;outside&quot;,&quot;getwid_dots&quot;:&quot;none&quot;}\" class=\"wp-block-getwid-post-carousel__wrapper\">\n                \t\t\t\t\t\t\t<div class=\"wp-block-getwid-post-carousel__slide\">\n\t\t\t\t\t\t\t\t\n<div class=\"wp-block-uagb-section uagb-section__wrap uagb-section__background-undefined uagb-block-9380a746 evtgroup\"><div class=\"uagb-section__overlay\"><\/div><div class=\"uagb-section__inner-wrap\">\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h3 style=\"color:#03315e;\" class=\"wp-block-getwid-template-post-title has-medium-font-size has-text-color\"><a class=\"wp-block-getwid-template-post-title__link\" href=\"https:\/\/www.icta.fr\/fr\/expertises\/developpement-clinique\/\">D\u00e9veloppement clinique<\/a><\/h3>\n\n\n<div class=\"wp-block-getwid-template-post-featured-image\" >\n        <img decoding=\"async\" width=\"364\" height=\"240\" src=\"https:\/\/www.icta.fr\/wp-content\/uploads\/clinical-development-icta-364x240.png\" class=\"attachment-wpm_taille_1 size-wpm_taille_1 wp-post-image\" alt=\"D\u00e9veloppement clinique\" \/>    <\/div>\n\n\n\n<div class=\"wp-block-getwid-template-post-content is-excerpt\" ><p>B\u00e9n\u00e9ficiez de l&#039;exp\u00e9rience de nos experts en R&amp;D clinique pour choisir la bonne strat\u00e9gie clinique.\u2026<\/p><\/div>\n<\/div>\n<\/div>\n<\/div><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"wp-block-getwid-post-carousel__slide\">\n\t\t\t\t\t\t\t\t\n<div class=\"wp-block-uagb-section uagb-section__wrap uagb-section__background-undefined uagb-block-9380a746 evtgroup\"><div class=\"uagb-section__overlay\"><\/div><div class=\"uagb-section__inner-wrap\">\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h3 style=\"color:#03315e;\" class=\"wp-block-getwid-template-post-title has-medium-font-size has-text-color\"><a class=\"wp-block-getwid-template-post-title__link\" href=\"https:\/\/www.icta.fr\/fr\/expertises\/acces-precoce\/\">Acc\u00e8s pr\u00e9coce<\/a><\/h3>\n\n\n<div class=\"wp-block-getwid-template-post-featured-image\" >\n        <img decoding=\"async\" width=\"364\" height=\"240\" src=\"https:\/\/www.icta.fr\/wp-content\/uploads\/early-access-icta-364x240.png\" class=\"attachment-wpm_taille_1 size-wpm_taille_1 wp-post-image\" alt=\"Acc\u00e8s pr\u00e9coce\" \/>    <\/div>\n\n\n\n<div class=\"wp-block-getwid-template-post-content is-excerpt\" ><p>Il y a 18 ans, ICTA cr\u00e9ait un d\u00e9partement d\u00e9di\u00e9 \u00e0 la conduite des programmes\u2026<\/p><\/div>\n<\/div>\n<\/div>\n<\/div><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"wp-block-getwid-post-carousel__slide\">\n\t\t\t\t\t\t\t\t\n<div class=\"wp-block-uagb-section uagb-section__wrap uagb-section__background-undefined uagb-block-9380a746 evtgroup\"><div class=\"uagb-section__overlay\"><\/div><div class=\"uagb-section__inner-wrap\">\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h3 style=\"color:#03315e;\" class=\"wp-block-getwid-template-post-title has-medium-font-size has-text-color\"><a class=\"wp-block-getwid-template-post-title__link\" href=\"https:\/\/www.icta.fr\/fr\/expertises\/etudes-en-vie-reelle\/\">\u00c9tudes en vie r\u00e9elle<\/a><\/h3>\n\n\n<div class=\"wp-block-getwid-template-post-featured-image\" >\n        <img decoding=\"async\" width=\"364\" height=\"240\" src=\"https:\/\/www.icta.fr\/wp-content\/uploads\/real-world-evidence-icta-364x240.png\" class=\"attachment-wpm_taille_1 size-wpm_taille_1 wp-post-image\" alt=\"\u00c9tudes en vie r\u00e9elle\" \/>    <\/div>\n\n\n\n<div class=\"wp-block-getwid-template-post-content is-excerpt\" ><p>Dot\u00e9es d\u2019une vaste exp\u00e9rience dans l&#039;\u00e9valuation des donn\u00e9es de sant\u00e9), les \u00e9quipes ICTA sont \u00e0\u2026<\/p><\/div>\n<\/div>\n<\/div>\n<\/div><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"wp-block-getwid-post-carousel__slide\">\n\t\t\t\t\t\t\t\t\n<div class=\"wp-block-uagb-section uagb-section__wrap uagb-section__background-undefined uagb-block-9380a746 evtgroup\"><div class=\"uagb-section__overlay\"><\/div><div class=\"uagb-section__inner-wrap\">\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h3 style=\"color:#03315e;\" class=\"wp-block-getwid-template-post-title has-medium-font-size has-text-color\"><a class=\"wp-block-getwid-template-post-title__link\" href=\"https:\/\/www.icta.fr\/fr\/expertises\/analyse-donnees-de-sante\/\">Analyse des donn\u00e9es de sant\u00e9<\/a><\/h3>\n\n\n<div class=\"wp-block-getwid-template-post-featured-image\" >\n        <img decoding=\"async\" width=\"364\" height=\"240\" src=\"https:\/\/www.icta.fr\/wp-content\/uploads\/health-data-analysis-364x240.png\" class=\"attachment-wpm_taille_1 size-wpm_taille_1 wp-post-image\" alt=\"Analyse des donn\u00e9es de sant\u00e9\" \/>    <\/div>\n\n\n\n<div class=\"wp-block-getwid-template-post-content is-excerpt\" ><p>Aujourd&#039;hui, nous avons acc\u00e8s \u00e0 des sources de donn\u00e9es de plus en plus volumineuses. Les\u2026<\/p><\/div>\n<\/div>\n<\/div>\n<\/div><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"wp-block-getwid-post-carousel__slide\">\n\t\t\t\t\t\t\t\t\n<div class=\"wp-block-uagb-section uagb-section__wrap uagb-section__background-undefined uagb-block-9380a746 evtgroup\"><div class=\"uagb-section__overlay\"><\/div><div class=\"uagb-section__inner-wrap\">\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h3 style=\"color:#03315e;\" class=\"wp-block-getwid-template-post-title has-medium-font-size has-text-color\"><a class=\"wp-block-getwid-template-post-title__link\" href=\"https:\/\/www.icta.fr\/fr\/expertises\/biotechnologie\/\">Biotechnologie<\/a><\/h3>\n\n\n<div class=\"wp-block-getwid-template-post-featured-image\" >\n        <img decoding=\"async\" width=\"364\" height=\"240\" src=\"https:\/\/www.icta.fr\/wp-content\/uploads\/biotech-icta-364x240.png\" class=\"attachment-wpm_taille_1 size-wpm_taille_1 wp-post-image\" alt=\"Biotechnologie\" \/>    <\/div>\n\n\n\n<div class=\"wp-block-getwid-template-post-content is-excerpt\" ><p>Vous \u00eates une entreprise de biotechnologie \u00e0 la recherche d\u2019un partenaire comp\u00e9tent pour vous accompagner\u2026<\/p><\/div>\n<\/div>\n<\/div>\n<\/div><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"wp-block-getwid-post-carousel__slide\">\n\t\t\t\t\t\t\t\t\n<div class=\"wp-block-uagb-section uagb-section__wrap uagb-section__background-undefined uagb-block-9380a746 evtgroup\"><div class=\"uagb-section__overlay\"><\/div><div class=\"uagb-section__inner-wrap\">\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h3 style=\"color:#03315e;\" class=\"wp-block-getwid-template-post-title has-medium-font-size has-text-color\"><a class=\"wp-block-getwid-template-post-title__link\" href=\"https:\/\/www.icta.fr\/fr\/expertises\/dispositif-medical\/\">Dispositif m\u00e9dical<\/a><\/h3>\n\n\n<div class=\"wp-block-getwid-template-post-featured-image\" >\n        <img decoding=\"async\" width=\"364\" height=\"240\" src=\"https:\/\/www.icta.fr\/wp-content\/uploads\/medical-device-icta-364x240.png\" class=\"attachment-wpm_taille_1 size-wpm_taille_1 wp-post-image\" alt=\"Dispositif m\u00e9dical\" \/>    <\/div>\n\n\n\n<div class=\"wp-block-getwid-template-post-content is-excerpt\" ><p>L\u2019\u00e9valuation clinique portant sur les dispositifs m\u00e9dicaux est une n\u00e9cessit\u00e9 en vertu du r\u00e8glement sur\u2026<\/p><\/div>\n<\/div>\n<\/div>\n<\/div><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"wp-block-getwid-post-carousel__slide\">\n\t\t\t\t\t\t\t\t\n<div class=\"wp-block-uagb-section uagb-section__wrap uagb-section__background-undefined uagb-block-9380a746 evtgroup\"><div class=\"uagb-section__overlay\"><\/div><div class=\"uagb-section__inner-wrap\">\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h3 style=\"color:#03315e;\" class=\"wp-block-getwid-template-post-title has-medium-font-size has-text-color\"><a class=\"wp-block-getwid-template-post-title__link\" href=\"https:\/\/www.icta.fr\/fr\/expertises\/etudes-decentralisees\/\">\u00c9tudes d\u00e9centralis\u00e9es<\/a><\/h3>\n\n\n<div class=\"wp-block-getwid-template-post-featured-image\" >\n        <img decoding=\"async\" width=\"364\" height=\"240\" src=\"https:\/\/www.icta.fr\/wp-content\/uploads\/decentralized-studies-icta-364x240.png\" class=\"attachment-wpm_taille_1 size-wpm_taille_1 wp-post-image\" alt=\"\u00c9tudes d\u00e9centralis\u00e9es\" \/>    <\/div>\n\n\n\n<div class=\"wp-block-getwid-template-post-content is-excerpt\" ><p>Notre triple expertise dans les domaines de la r\u00e9glementation, du num\u00e9rique et de la logistique,\u2026<\/p><\/div>\n<\/div>\n<\/div>\n<\/div><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t            <\/div>\n        <\/div>\n        \n\n\n<div class=\"wp-block-buttons is-horizontal is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-7d812b4c wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button is-style-boutontypebleu\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/www.icta.fr\/fr\/expertises\/\">Voir les domaines d&#8217;expertise<\/a><\/div>\n<\/div>\n<\/div><\/section>\n\n\n\n<section class=\"wp-block-uagb-section uagb-section__wrap uagb-section__background-undefined uagb-block-eb6a4b7a\"><div class=\"uagb-section__overlay\"><\/div><div class=\"uagb-section__inner-wrap\">\n<div class=\"wp-block-columns container is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large is-resized\"><img decoding=\"async\" width=\"126\" height=\"126\" src=\"https:\/\/www.icta.fr\/wp-content\/uploads\/tampon-conformite-rgpd.png\" alt=\"RGPD compliant\" class=\"wp-image-143\" style=\"width:200px\"\/><\/figure>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large is-resized\"><img decoding=\"async\" width=\"122\" height=\"122\" src=\"https:\/\/www.icta.fr\/wp-content\/uploads\/21cfr.png\" alt=\"21 CFR Part 11 compliance\" class=\"wp-image-144\" style=\"width:200px\"\/><\/figure>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\"><div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full is-resized\"><img decoding=\"async\" width=\"1200\" height=\"1200\" src=\"https:\/\/www.icta.fr\/wp-content\/uploads\/Design-sans-titre-3.png\" alt=\"ecovadis 2024 bronze\" class=\"wp-image-10802\" style=\"width:200px\" srcset=\"https:\/\/www.icta.fr\/wp-content\/uploads\/Design-sans-titre-3.png 1200w, https:\/\/www.icta.fr\/wp-content\/uploads\/Design-sans-titre-3-300x300.png 300w, https:\/\/www.icta.fr\/wp-content\/uploads\/Design-sans-titre-3-1024x1024.png 1024w, https:\/\/www.icta.fr\/wp-content\/uploads\/Design-sans-titre-3-768x768.png 768w\" sizes=\"(max-width: 1200px) 100vw, 1200px\" \/><\/figure>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><div class=\"wp-block-image is-resized\">\n<figure class=\"aligncenter size-full\"><img decoding=\"async\" width=\"800\" height=\"800\" src=\"https:\/\/www.icta.fr\/wp-content\/uploads\/logo-agree-cir.png\" alt=\"cr\u00e9dit d'imp\u00f4t recherche\" class=\"wp-image-5987\" style=\"width:200px\" srcset=\"https:\/\/www.icta.fr\/wp-content\/uploads\/logo-agree-cir.png 800w, https:\/\/www.icta.fr\/wp-content\/uploads\/logo-agree-cir-300x300.png 300w, https:\/\/www.icta.fr\/wp-content\/uploads\/logo-agree-cir-768x768.png 768w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/><\/figure>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\"><div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full is-resized\"><img decoding=\"async\" width=\"150\" height=\"77\" src=\"https:\/\/www.icta.fr\/wp-content\/uploads\/BV_Certification_ISO27001-3.jpg\" alt=\"bureau veritas certification icta\" class=\"wp-image-5968\" style=\"width:200px\"\/><\/figure>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\"><div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full is-resized\"><img decoding=\"async\" width=\"150\" height=\"71\" src=\"https:\/\/www.icta.fr\/wp-content\/uploads\/BV_Certification_ISO-9001-2015-1.jpg\" alt=\"bureau veritas certification icta\" class=\"wp-image-5969\" style=\"width:200px\"\/><\/figure>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\"><div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full is-resized\"><img decoding=\"async\" width=\"669\" height=\"651\" src=\"https:\/\/www.icta.fr\/wp-content\/uploads\/CDP2024.jpg\" alt=\"\" class=\"wp-image-10125\" style=\"width:200px\" srcset=\"https:\/\/www.icta.fr\/wp-content\/uploads\/CDP2024.jpg 669w, https:\/\/www.icta.fr\/wp-content\/uploads\/CDP2024-300x292.jpg 300w\" sizes=\"(max-width: 669px) 100vw, 669px\" \/><\/figure>\n<\/div><\/div>\n<\/div>\n<\/div><\/section>\n","protected":false},"excerpt":{"rendered":"<p>L\u2019\u00e9valuation clinique portant sur les dispositifs m\u00e9dicaux est une n\u00e9cessit\u00e9 en vertu du r\u00e8glement sur les dispositifs m\u00e9dicaux (UE) 2017\/745 (MDR).<\/p>\n<p>Notre exp\u00e9rience des exigences cliniques et r\u00e9glementaires propres aux investigations cliniques des dispositifs m\u00e9dicaux et de diagnostic in-vitro vous garantissent un accompagnement fiable dans la conception, la mise en \u0153uvre et la gestion du plan d\u2019investigation clinique de votre dispositif m\u00e9dical (avant et apr\u00e8s commercialisation).<\/p>\n","protected":false},"author":1,"featured_media":7330,"comment_status":"open","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":2,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","inline_featured_image":false,"_uag_custom_page_level_css":"","kk_blocks_editor_width":"","_kiokenblocks_attr":"","_kiokenblocks_dimensions":"","footnotes":""},"class_list":["post-1275","domaineexpertises","type-domaineexpertises","status-publish","has-post-thumbnail","hentry"],"acf":[],"uagb_featured_image_src":{"full":["https:\/\/www.icta.fr\/wp-content\/uploads\/medical-device-icta.png",375,240,false],"thumbnail":["https:\/\/www.icta.fr\/wp-content\/uploads\/medical-device-icta-128x88.png",128,88,true],"medium":["https:\/\/www.icta.fr\/wp-content\/uploads\/medical-device-icta-300x192.png",300,192,true],"medium_large":["https:\/\/www.icta.fr\/wp-content\/uploads\/medical-device-icta.png",375,240,false],"large":["https:\/\/www.icta.fr\/wp-content\/uploads\/medical-device-icta.png",375,240,false],"1536x1536":["https:\/\/www.icta.fr\/wp-content\/uploads\/medical-device-icta.png",375,240,false],"2048x2048":["https:\/\/www.icta.fr\/wp-content\/uploads\/medical-device-icta.png",375,240,false],"post-thumbnail":["https:\/\/www.icta.fr\/wp-content\/uploads\/medical-device-icta.png",375,240,false],"wpm_taille_1":["https:\/\/www.icta.fr\/wp-content\/uploads\/medical-device-icta-364x240.png",364,240,true],"wpm_taille_slider":["https:\/\/www.icta.fr\/wp-content\/uploads\/medical-device-icta-240x145.png",240,145,true],"gform-image-choice-sm":["https:\/\/www.icta.fr\/wp-content\/uploads\/medical-device-icta.png",300,192,false],"gform-image-choice-md":["https:\/\/www.icta.fr\/wp-content\/uploads\/medical-device-icta.png",375,240,false],"gform-image-choice-lg":["https:\/\/www.icta.fr\/wp-content\/uploads\/medical-device-icta.png",375,240,false]},"uagb_author_info":{"display_name":"ictvsi6372","author_link":"https:\/\/www.icta.fr\/fr\/author\/jhvision-icta\/"},"uagb_comment_info":0,"uagb_excerpt":"L\u2019\u00e9valuation clinique portant sur les dispositifs m\u00e9dicaux est une n\u00e9cessit\u00e9 en vertu du r\u00e8glement sur les dispositifs m\u00e9dicaux (UE) 2017\/745 (MDR). 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