{"id":4241,"date":"2024-11-14T16:35:55","date_gmt":"2024-11-14T15:35:55","guid":{"rendered":"https:\/\/www.selenium-medical.com\/?p=4241"},"modified":"2025-02-25T14:13:22","modified_gmt":"2025-02-25T14:13:22","slug":"inspections-reussies-iso-13485-fda-anvisa","status":"publish","type":"post","link":"https:\/\/www.selenium-medical.com\/fr\/2024\/11\/14\/inspections-reussies-iso-13485-fda-anvisa\/","title":{"rendered":"Inspections r\u00e9ussies : ISO 13485, FDA &#038; ANVISA"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row][vc_column][vc_column_text css=\u00a0\u00bb\u00a0\u00bb]<strong>Selenium Medical a renouvel\u00e9 sa certification ISO 13485 et a pass\u00e9 avec succ\u00e8s les inspections FDA et ANVISA.<\/strong><\/p>\n<h1><strong>Selenium Medical : Audit ISO 13485 et Inspections FDA &amp; ANVISA<\/strong><\/h1>\n<p>Chez\u00a0<strong>Selenium Medical<\/strong>, nous nous engageons \u00e0 garantir la <a href=\"https:\/\/www.selenium-medical.com\/fr\/presentation\/qualite\/\">qualit\u00e9<\/a> et la s\u00e9curit\u00e9 des dispositifs m\u00e9dicaux que nous sous-traitons pour le compte de nos clients. Nos processus de production et nos services sont rigoureusement contr\u00f4l\u00e9s. Ils respectent les normes les plus strictes, assurant des produits s\u00fbrs et fiables destin\u00e9s aux patients et aux professionnels de sant\u00e9. Vous pouvez t\u00e9l\u00e9charger notre certification <a href=\"https:\/\/www.selenium-medical.com\/fr\/presentation\/qualite\/\">ici.\u00a0<\/a><\/p>\n<ul>\n<li><strong>ISO 13485<\/strong><\/li>\n<\/ul>\n<p>Nous avons r\u00e9cemment obtenu le renouvellement de notre\u00a0<strong>certification ISO 13485<\/strong>, norme cl\u00e9 pour la gestion de la qualit\u00e9 des dispositifs m\u00e9dicaux. Cette certification est indispensable pour l&rsquo;obtention du\u00a0<strong>marquage CE. <\/strong>Ainsi, elle permet\u00a0d&rsquo;assurer que les dispositifs m\u00e9dicaux r\u00e9pondent aux exigences de s\u00e9curit\u00e9 et de performance du march\u00e9 europ\u00e9en. Ce renouvellement atteste de notre engagement continu \u00e0 maintenir des standards \u00e9lev\u00e9s <strong>en mati\u00e8re de qualit\u00e9 et de s\u00e9curit\u00e9 des produits.<\/strong><\/p>\n<ul>\n<li><strong>FDA (Food and Drug Administration)<\/strong><\/li>\n<\/ul>\n<p>Dans le cadre d&rsquo;une inspection <strong>FDA <\/strong>\u00a0pour un <strong>Premarket Approval (PMA)<\/strong> de l\u2019un de nos clients, nous avons obtenu un r\u00e9sultat avec z\u00e9ro non-conformit\u00e9. Cette inspection est cruciale pour l&rsquo;autorisation de mise sur le march\u00e9 d&rsquo;un dispositif m\u00e9dical aux \u00c9tats-Unis. Par cons\u00e9quent, elle a permis de valider la conformit\u00e9 de nos pratiques aux exigences strictes de la FDA en mati\u00e8re de bonnes pratiques de fabrication (GMP) et de gestion des risques.<\/p>\n<ul>\n<li><strong>ANVISA<\/strong><\/li>\n<\/ul>\n<div class=\"flex max-w-full flex-col flex-grow\">\n<div class=\"min-h-8 text-message flex w-full flex-col items-end gap-2 whitespace-normal break-words [.text-message+&amp;]:mt-5\" dir=\"auto\" data-message-author-role=\"assistant\" data-message-id=\"5eb089c4-d28b-4f47-9989-5c968970210c\" data-message-model-slug=\"gpt-4o\">\n<div class=\"flex w-full flex-col gap-1 empty:hidden first:pt-[3px]\">\n<div class=\"markdown prose w-full break-words dark:prose-invert light\">\n<p>Nous avons r\u00e9cemment franchi une \u00e9tape importante avec notre premi\u00e8re inspection ANVISA. Celle-ci a \u00e9t\u00e9 conduite par l\u2019agence br\u00e9silienne de r\u00e9gulation des produits de sant\u00e9. L\u2019inspection s&rsquo;est bien d\u00e9roul\u00e9e et a \u00e9t\u00e9 r\u00e9alis\u00e9e pour l\u2019un de nos clients en vue de la commercialisation de dispositifs m\u00e9dicaux au Br\u00e9sil.<\/p>\n<p>&nbsp;<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<h2><strong>Engag\u00e9s pour garantir la qualit\u00e9 et la s\u00e9curit\u00e9 des DM<\/strong><\/h2>\n<p>Ces r\u00e9ussites successives, illustrent l\u2019engagement de\u00a0<strong>Selenium Medical<\/strong> et de ses \u00e9quipes. Nous maintenons des standards de <strong>qualit\u00e9 et de s\u00e9curit\u00e9<\/strong> \u00e9lev\u00e9s et respectons les exigences r\u00e9glementaires les plus strictes. Ainsi, cela t\u00e9moigne \u00e9galement de notre capacit\u00e9 \u00e0 offrir \u00e0 nos clients des solutions fiables. En outre, conformes aux exigences r\u00e9glementaires les plus complexes, et ce, dans un environnement international. Nous restons pleinement engag\u00e9s dans l\u2019am\u00e9lioration continue de nos pratiques. Dans le but de soutenir nos clients et leurs projets et contribuer \u00e0 la s\u00e9curit\u00e9 des patients \u00e0 travers le monde.<\/p>\n<p>Pour en savoir plus sur nos services ou discuter de vos projets, n\u2019h\u00e9sitez pas \u00e0 <strong>nous contacter<\/strong>. En outre, vous pouvez nous suivre sur <a href=\"https:\/\/www.linkedin.com\/company\/5825094\/admin\/dashboard\/\"><strong>LinkedIn<\/strong><\/a> pour d\u00e9couvrir nos derni\u00e8res actualit\u00e9s.[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_btn title=\u00a0\u00bbNous contacter\u00a0\u00bb style=\u00a0\u00bbclassic\u00a0\u00bb color=\u00a0\u00bbprimary\u00a0\u00bb css=\u00a0\u00bb\u00a0\u00bb link=\u00a0\u00bburl:https%3A%2F%2Fwww.selenium-medical.com%2Ffr%2Fcontact%2F|title:Contact\u00a0\u00bb][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column][vc_column_text css=\u00a0\u00bb\u00a0\u00bb]Selenium Medical a renouvel\u00e9 sa certification ISO 13485 et a pass\u00e9 avec succ\u00e8s les inspections FDA et ANVISA. Selenium Medical : Audit ISO 13485 et Inspections FDA &amp; ANVISA Chez\u00a0Selenium Medical, nous nous engageons \u00e0 garantir la qualit\u00e9 et la s\u00e9curit\u00e9 des dispositifs m\u00e9dicaux que nous sous-traitons pour le compte de nos clients. Nos [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":4242,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[39,44],"class_list":["post-4241","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actualite","category-certifications"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Inspections r\u00e9ussies : ISO 13485, FDA &amp; ANVISA<\/title>\n<meta name=\"description\" content=\"Selenium Medical a renouvel\u00e9 sa certification ISO 13485 et a pass\u00e9 avec succ\u00e8s les inspections FDA et ANVISA.\" \/>\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.selenium-medical.com\/fr\/2024\/11\/14\/inspections-reussies-iso-13485-fda-anvisa\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Inspections r\u00e9ussies : ISO 13485, FDA &amp; 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