{"id":57976,"date":"2025-01-03T13:53:06","date_gmt":"2025-01-03T13:53:06","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/formation-ivdr-reglement-2017-746-relatif-aux-dispositifs-medicaux-de-diagnostic-in-vitro\/"},"modified":"2025-01-03T13:53:06","modified_gmt":"2025-01-03T12:53:06","slug":"formation-ivdr-reglement-2017-746-relatif-aux-dispositifs-medicaux-de-diagnostic-in-vitro","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/fr\/online-course\/formation-ivdr-reglement-2017-746-relatif-aux-dispositifs-medicaux-de-diagnostic-in-vitro\/","title":{"rendered":"Formation IVDR : R\u00e8glement 2017\/746 relatif aux dispositifs m\u00e9dicaux de diagnostic in vitro"},"content":{"rendered":"<div class=\"flex-shrink-0 flex flex-col relative items-end\">\n<div>\n<div class=\"pt-0\">\n<div class=\"gizmo-bot-avatar flex h-8 w-8 items-center justify-center overflow-hidden rounded-full\">\n<div class=\"relative p-1 rounded-sm flex items-center justify-center bg-token-main-surface-primary text-token-text-primary h-8 w-8\">\n<div class=\"flex-shrink-0 flex flex-col relative items-end\">\n<div>\n<div class=\"pt-0\">\n<div class=\"gizmo-bot-avatar flex h-8 w-8 items-center justify-center overflow-hidden rounded-full\">\n<div class=\"relative p-1 rounded-sm flex items-center justify-center bg-token-main-surface-primary text-token-text-primary h-8 w-8\">Savez-vous comment le <a href=\"https:\/\/health.ec.europa.eu\/medical-devices-sector\/new-regulations_en\">nouvel IVDR de l\u2019UE<\/a> impactera votre entreprise ? Il concerne tous les op\u00e9rateurs \u00e9conomiques de la cha\u00eene d\u2019approvisionnement, y compris les fabricants, distributeurs, importateurs et mandataires. <strong>La conformit\u00e9 \u00e0 l\u2019IVDR est obligatoire pour garantir l\u2019acc\u00e8s au march\u00e9 et maintenir l\u2019approbation r\u00e9glementaire<\/strong>. Pour aider votre organisation \u00e0 se conformer aux nouvelles exigences de l\u2019IVDR, GxP Training propose un cours certifi\u00e9 en ligne comprenant 9 modules.  <\/div>\n<div><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p>&nbsp;<\/p>\n<p><b>\u00c0 qui s\u2019adresse cette formation ?<\/b><\/p>\n<p>Ce cours est con\u00e7u pour les professionnels du secteur des <a href=\"https:\/\/gxp-training.com\/fr\/gxp-courses\/dispositifs-medicaux\/\">dispositifs m\u00e9dicaux<\/a> de diagnostic in vitro (DIV). Il est id\u00e9al pour les personnes travaillant dans les affaires r\u00e9glementaires, la conception et le d\u00e9veloppement, la gestion\/assurance qualit\u00e9, l\u2019ing\u00e9nierie qualit\u00e9, l\u2019audit interne, les mandataires et les PRRC. <\/p>\n<p>&nbsp;<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p><b>Objectifs d\u2019apprentissage : <\/b><\/p>\n<p>\u00c0 l\u2019issue de ce cours, les participants seront capables de :<\/p>\n<ul>\n<li>Comprendre le cadre de l\u2019UE IVDR 2017\/746<\/li>\n<li>Identifier et classer les dispositifs m\u00e9dicaux de DIV<\/li>\n<li>Reconna\u00eetre les r\u00f4les et responsabilit\u00e9s des op\u00e9rateurs \u00e9conomiques<\/li>\n<li>Expliquer les exigences g\u00e9n\u00e9rales en mati\u00e8re de s\u00e9curit\u00e9 et de performances (GSPR)<\/li>\n<li>Comprendre les exigences de conformit\u00e9 continue (surveillance apr\u00e8s commercialisation et mat\u00e9riovigilance)<\/li>\n<li>D\u00e9crire la documentation technique et les exigences relatives \u00e0 l\u2019UDI<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>Un cours certifi\u00e9 par GxP Training offre une exp\u00e9rience d\u2019apprentissage hautement interactive. Chaque session int\u00e8gre des exemples concrets et des quiz. Une fois termin\u00e9, les participants recevront un certificat de formation reconnu mondialement, accr\u00e9dit\u00e9 par des cr\u00e9dits CPD\/CEU.  <\/p>\n<p>&nbsp;<\/p>\n<h3><b>Programme :<\/b><\/h3>\n<p><b>Introduction<\/b><\/p>\n<p><b>Le\u00e7on 1 : Aper\u00e7u du r\u00e8glement<\/b><\/p>\n<p><b>Le\u00e7on 2 : Qu\u2019est-ce qu\u2019un dispositif m\u00e9dical de diagnostic in vitro ?<\/b><\/p>\n<p><b>Le\u00e7on 3 : Classification des dispositifs m\u00e9dicaux de diagnostic in vitro<\/b><\/p>\n<p><b>Le\u00e7on 4 : Op\u00e9rateur \u00e9conomique<\/b><\/p>\n<p><b>Le\u00e7on 5 : EUDAMED<\/b><\/p>\n<p><b>Le\u00e7on 6 : UDI et enregistrement<\/b><\/p>\n<p><b>Le\u00e7on 7 : \u00c9valuation de la conformit\u00e9<\/b><\/p>\n<p><b>Le\u00e7on 8 : Preuves cliniques suffisantes<\/b><\/p>\n<p><b>Le\u00e7on 9 : Surveillance apr\u00e8s commercialisation<\/b><\/p>\n<p><b>Conclusion<\/b><\/p>\n<p><b>\u00c9valuation<\/b><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Savez-vous comment le nouvel IVDR de l\u2019UE impactera votre entreprise ? Il concerne tous les op\u00e9rateurs \u00e9conomiques de la cha\u00eene d\u2019approvisionnement, y compris les fabricants, distributeurs, importateurs et mandataires. La conformit\u00e9 \u00e0 l\u2019IVDR est obligatoire pour garantir l\u2019acc\u00e8s au march\u00e9 et maintenir l\u2019approbation r\u00e9glementaire. Pour aider votre organisation \u00e0 se conformer aux nouvelles exigences de [&hellip;]<\/p>\n","protected":false},"featured_media":48722,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[255,256],"product_tag":[],"class_list":{"0":"post-57976","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-affaires-reglementaires","7":"product_cat-dispositifs-medicaux","9":"first","10":"instock","11":"taxable","12":"shipping-taxable","13":"purchasable","14":"product-type-subscription"},"bundled_by":[],"bundle_stock_status":"instock","bundle_stock_quantity":null,"bundle_virtual":false,"bundle_layout":"","bundle_add_to_cart_form_location":"","bundle_editable_in_cart":false,"bundle_sold_individually_context":"","bundle_item_grouping":"","bundle_min_size":"","bundle_max_size":"","bundle_price":[],"bundled_items":[],"bundle_sell_ids":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>IVDR 2017\/746 : Formation certifiante sur la r\u00e9glementation des dispositifs m\u00e9dicaux<\/title>\n<meta name=\"description\" content=\"Cours en ligne certifi\u00e9 IVDR 2017\/746 couvrant la conformit\u00e9, l\u2019UDI, EUDAMED et la surveillance apr\u00e8s commercialisation. 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