{"id":7173,"date":"2025-06-19T13:50:49","date_gmt":"2025-06-19T04:50:49","guid":{"rendered":"https:\/\/www.drgemhealthcare.com\/?p=7173"},"modified":"2025-06-23T09:13:12","modified_gmt":"2025-06-23T00:13:12","slug":"drgem-achieves-eu-mdr-certification","status":"publish","type":"post","link":"https:\/\/www.drgemhealthcare.com\/fr\/drgem-achieves-eu-mdr-certification\/","title":{"rendered":"DRGEM obtient la certification MDR de l'UE"},"content":{"rendered":"<figure class=\"wp-block-image size-large\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"1024\" src=\"https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2025\/06\/image-10-1024x1024.png\" alt=\"\" class=\"wp-image-7174\" srcset=\"https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2025\/06\/image-10-1024x1024.png 1024w, https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2025\/06\/image-10-300x300.png 300w, https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2025\/06\/image-10-150x150.png 150w, https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2025\/06\/image-10-768x768.png 768w, https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2025\/06\/image-10-12x12.png 12w, https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2025\/06\/image-10.png 1080w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p class=\"translation-block\">DRGEM a le plaisir d'annoncer que la soci\u00e9t\u00e9 a obtenu la certification <strong>EU MDR (European Union Medical Device Regulation 2017\/745)<\/strong> \u00e0 compter du 12 juin 2025.<\/p>\n\n\n\n<p>L'EU MDR est une exigence obligatoire pour la vente de dispositifs m\u00e9dicaux en Europe et est bien connue pour ses normes r\u00e9glementaires strictes. \u00c0 la suite d'une s\u00e9rie d'incidents li\u00e9s \u00e0 des dispositifs m\u00e9dicaux en Europe, ces exigences sont devenues beaucoup plus strictes. Comme l'indique la r\u00e9solution du Parlement europ\u00e9en (TA-10-2024-0028), le RIM fixe des normes exigeantes, ce qui rend la certification difficile pour de nombreux fabricants.<\/p>\n\n\n\n<p>Malgr\u00e9 cet environnement difficile, DRGEM a r\u00e9ussi \u00e0 obtenir la certification MDR en respectant toutes les normes requises. Cet accomplissement montre que ses produits r\u00e9pondent aux niveaux les plus \u00e9lev\u00e9s de s\u00e9curit\u00e9, de performance et de qualit\u00e9 tout au long de leur cycle de vie, y compris la conception, la fabrication, la validation clinique et la gestion de la qualit\u00e9.<\/p>\n\n\n\n<p>Les produits DRGEM suivants sont d\u00e9sormais certifi\u00e9s par le r\u00e8glement MDR de l'UE :<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Syst\u00e8me de diagnostic par rayons X<\/li>\n\n\n\n<li>Syst\u00e8me de radiodiagnostic num\u00e9rique<\/li>\n\n\n\n<li>Syst\u00e8me mobile de radiographie<\/li>\n\n\n\n<li>Syst\u00e8me d'imagerie num\u00e9rique<\/li>\n\n\n\n<li>G\u00e9n\u00e9rateur de rayons X \u00e0 haute tension<\/li>\n\n\n\n<li>Anode tournante Rayon X Tube Assemblage<\/li>\n\n\n\n<li>Collimateur de rayons X<\/li>\n<\/ul>\n\n\n\n<p>\u3000<\/p>\n\n\n\n<p>Ces produits certifi\u00e9s sont officiellement autoris\u00e9s \u00e0 \u00eatre distribu\u00e9s sur le march\u00e9 europ\u00e9en et sont reconnus comme \u00e9tant conformes aux attentes r\u00e9glementaires mondiales. La certification renforce la comp\u00e9titivit\u00e9 mondiale de DRGEM et accro\u00eet la confiance des partenaires et des clients dans son portefeuille de produits en expansion, soutenu par un r\u00e9seau mondial solide de plus de 200 partenaires.<\/p>\n\n\n\n<p>En tant que partenaire engag\u00e9 et fiable, DRGEM continuera \u00e0 fournir des syst\u00e8mes de radiologie qui r\u00e9pondent non seulement aux attentes cliniques, mais aussi aux normes r\u00e9glementaires internationales les plus avanc\u00e9es. L'entreprise appr\u00e9cie les partenariats en cours alors qu'elle poursuit sa mission de faire progresser l'imagerie m\u00e9dicale.<\/p>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>DRGEM is pleased to announce that the company has achieved EU MDR (European Union Medical Device Regulation 2017\/745) certification as of June 12, 2025. EU MDR is a mandatory requirement for selling medical devices in Europe and is well known for its strict regulatory standards. Following a series of medical device incidents within Europe, these [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":7174,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_uf_show_specific_survey":0,"_uf_disable_surveys":false,"footnotes":""},"categories":[14],"tags":[],"class_list":["post-7173","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-drgem-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.0 (Yoast SEO v27.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>DRGEM Achieves EU MDR Certification - DRGEM<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.drgemhealthcare.com\/fr\/drgem-achieves-eu-mdr-certification\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"DRGEM Achieves EU MDR Certification\" \/>\n<meta property=\"og:description\" content=\"DRGEM is pleased to announce that the company has achieved EU MDR (European Union Medical Device Regulation 2017\/745) certification as of June 12, 2025. 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