{"id":7856,"date":"2022-06-30T09:48:04","date_gmt":"2022-06-30T09:48:04","guid":{"rendered":"https:\/\/r-biopharm.com\/?p=7856"},"modified":"2022-07-01T11:30:21","modified_gmt":"2022-07-01T11:30:21","slug":"r-biopharm-est-certifie-ivdr","status":"publish","type":"post","link":"https:\/\/r-biopharm.com\/fr\/r-biopharm-est-certifie-ivdr\/","title":{"rendered":"R-Biopharm est certifi\u00e9 IVDR"},"content":{"rendered":"<div class=\"wpb-content-wrapper\">[vc_row][vc_column][vc_single_image image=\u00a0\u00bb7811&Prime; img_size=\u00a0\u00bbfull\u00a0\u00bb alignment=\u00a0\u00bbcenter\u00a0\u00bb][mk_padding_divider size=\u00a0\u00bb20&Prime;][vc_column_text css=\u00a0\u00bb.vc_custom_1656674773123{margin-bottom: 0px !important;}\u00a0\u00bb]La poursuite de la qualit\u00e9 fait partie int\u00e9grante de la culture et des processus chez R-Biopharm AG. Cette soci\u00e9t\u00e9 de biotechnologie bas\u00e9e dans le sud de la Hesse, en Allemagne, s\u2019assure ainsi que la qualit\u00e9 est pleinement int\u00e9gr\u00e9e dans la soci\u00e9t\u00e9 et constamment am\u00e9lior\u00e9e dans le but de livrer des produits fiables sur le long terme. Cette soci\u00e9t\u00e9 familiale passe r\u00e9guli\u00e8rement des audits pour contr\u00f4ler l\u2019ad\u00e9quation et la fonctionnalit\u00e9 de tous les \u00e9l\u00e9ments li\u00e9s \u00e0 la qualit\u00e9. \u00c0 l\u2019automne 2021, R-Biopharm a \u00e9t\u00e9 l\u2019une des premi\u00e8res soci\u00e9t\u00e9s \u00e0 se soumettre \u00e0 un audit complet pour obtenir la nouvelle certification IVDR aupr\u00e8s de T\u00dcV S\u00dcD et elle vient tout juste de recevoir sa certification.[\/vc_column_text][mk_padding_divider size=\u00a0\u00bb20&Prime;][vc_single_image image=\u00a0\u00bb7826&Prime; img_size=\u00a0\u00bbfull\u00a0\u00bb alignment=\u00a0\u00bbright\u00a0\u00bb][mk_padding_divider size=\u00a0\u00bb20&Prime;][vc_column_text css=\u00a0\u00bb.vc_custom_1656674790348{margin-bottom: 0px !important;}\u00a0\u00bb]Les conditions, devenues obligatoires depuis mai 2022 pour les fabricants de dispositifs de diagnostic <em>in vitro<\/em> en Europe au terme d\u2019une phase de transition de cinq ans, en vertu du r\u00e8glement europ\u00e9en relatif aux dispositifs m\u00e9dicaux de diagnostic <em>in vitro<\/em>, sont d\u00e9j\u00e0 la norme pour la soci\u00e9t\u00e9 de biotechnologie depuis l\u2019automne 2021. La certification IVDR garantira que R-Biopharm peut continuer \u00e0 offrir ses outils de diagnostic clinique <em>in vitro<\/em> en Europe et dans le reste du monde en toute conformit\u00e9 avec les conditions l\u00e9gales plus strictes. Ayant renouvel\u00e9 dans le m\u00eame temps ses certifications pour le programme MDSAP (Medical Device Single Audit Program), les normes ISO\u00a09001:2015 et DIN EN ISO\u00a013485:2016 et la directive 98\/79\/CE relative aux dispositifs m\u00e9dicaux de diagnostic <em>in vitro<\/em>, R-Biopharm fait partie du nombre tr\u00e8s restreint de soci\u00e9t\u00e9s dans le monde qui b\u00e9n\u00e9ficient actuellement de la certification pour ces quatre normes.<\/p>\n<p>Par son syst\u00e8me holistique de gestion de la qualit\u00e9, R-Biopharm s\u2019assure que les conditions normatives et r\u00e9glementaires sont remplies depuis le d\u00e9veloppement jusqu\u2019\u00e0 la mise en application des produits, avec la mise en \u0153uvre de normes de grande qualit\u00e9. \u00ab\u00a0Dans notre soci\u00e9t\u00e9, la qualit\u00e9 ne rel\u00e8ve pas tant des agissements d\u2019une poign\u00e9e d\u2019entre nous, mais plut\u00f4t de l\u2019attitude de tous nos employ\u00e9s\u00a0\u00bb, d\u00e9clare le docteur Hans Frickel, membre du comit\u00e9 de direction. \u00ab\u00a0Notre focalisation sur la qualit\u00e9 a \u00e9galement tout son sens en interne. En appliquant des normes orient\u00e9es sur la qualit\u00e9, nous pouvons d\u00e9tecter les risques et les erreurs, concevoir avec efficacit\u00e9 les m\u00e9thodes de travail, identifier nos forces et nos potentiels, et en d\u00e9duire les actions n\u00e9cessaires qui nous aideront \u00e0 nous am\u00e9liorer sans cesse\u00a0\u00bb.[\/vc_column_text][\/vc_column][\/vc_row]\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column][vc_single_image image=\u00a0\u00bb7811&Prime; img_size=\u00a0\u00bbfull\u00a0\u00bb alignment=\u00a0\u00bbcenter\u00a0\u00bb][mk_padding_divider size=\u00a0\u00bb20&Prime;][vc_column_text css=\u00a0\u00bb.vc_custom_1656674773123{margin-bottom: 0px !important;}\u00a0\u00bb]La poursuite de la qualit\u00e9 fait partie int\u00e9grante de la culture et des processus chez R-Biopharm AG. Cette soci\u00e9t\u00e9 de biotechnologie bas\u00e9e dans le sud de la Hesse, en Allemagne, s\u2019assure ainsi que la qualit\u00e9 est pleinement int\u00e9gr\u00e9e dans la soci\u00e9t\u00e9 et constamment am\u00e9lior\u00e9e dans le but de [&hellip;]<\/p>\n","protected":false},"author":1114,"featured_media":7836,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[355],"tags":[],"class_list":["post-7856","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actualites"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>R-Biopharm est certifi\u00e9 IVDR - R-Biopharm AG<\/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:\/\/r-biopharm.com\/fr\/r-biopharm-est-certifie-ivdr\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"R-Biopharm est certifi\u00e9 IVDR - R-Biopharm AG\" \/>\n<meta property=\"og:description\" content=\"[vc_row][vc_column][vc_single_image image=\u00a0\u00bb7811&Prime; img_size=\u00a0\u00bbfull\u00a0\u00bb alignment=\u00a0\u00bbcenter\u00a0\u00bb][mk_padding_divider size=\u00a0\u00bb20&Prime;][vc_column_text css=\u00a0\u00bb.vc_custom_1656674773123{margin-bottom: 0px !important;}\u00a0\u00bb]La poursuite de la qualit\u00e9 fait partie int\u00e9grante de la culture et des processus chez R-Biopharm AG. 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