{"id":744,"date":"2017-01-05T17:17:05","date_gmt":"2017-01-05T16:17:05","guid":{"rendered":"https:\/\/m-q.ch\/?p=744"},"modified":"2017-01-10T12:58:37","modified_gmt":"2017-01-10T11:58:37","slug":"bfh-obtient-la-certification-iso-13485","status":"publish","type":"post","link":"https:\/\/www.m-q.ch\/fr\/bfh-obtient-la-certification-iso-13485\/","title":{"rendered":"Le BFH obtient la certification ISO-13485"},"content":{"rendered":"

La condition pr\u00e9alable \u00e0 la certification ISO-13485 est un syst\u00e8me de gestion complet pour la conception et la fabrication de dispositifs m\u00e9dicaux. Apr\u00e8s tout, garantir la s\u00e9curit\u00e9 et la sant\u00e9 des patients est essentiel, voire obligatoire, pour les dispositifs m\u00e9dicaux. Des directives strictes harmonis\u00e9es dans toute l'Europe exigent un contr\u00f4le de qualit\u00e9 et une surveillance du march\u00e9 continus. Un syst\u00e8me de gestion de la qualit\u00e9 certifi\u00e9 qui respecte ISO 13485<\/a>\u00a0est donc essentielle et, dans de nombreux cas, ne garantit que l'approbation et la commercialisation d'un dispositif m\u00e9dical.<\/p>\n

Un, deux ou trois ?<\/strong><\/p>\n

\"Actif, invasif ou implant\u00e9... ?\" Ce sont les termes des trois classes qu'il faut distinguer dans les dispositifs m\u00e9dicaux. \"Nous voulons les trois\", se sont dit les repr\u00e9sentants de l'\"Institut pour une ing\u00e9nierie centr\u00e9e sur l'homme\" de la Haute \u00e9cole sp\u00e9cialis\u00e9e bernoise (HESB), afin de pouvoir accompagner les d\u00e9veloppements de produits tout au long de leur cycle de vie. Concr\u00e8tement, un st\u00e9thoscope ou un fauteuil roulant pr\u00e9sentent un faible potentiel de risque et sont affect\u00e9s au groupe 1. Le groupe 2 comprend les produits pr\u00e9sentant un risque moyen \u00e0 \u00e9lev\u00e9, tels que les lentilles de contact, les appareils auditifs ou les appareils \u00e0 rayons X. Les stimulateurs cardiaques ou les proth\u00e8ses de genou, en revanche, sont class\u00e9s dans la 3e classe. Ces dispositifs m\u00e9dicaux pr\u00e9sentent donc le potentiel de risque le plus \u00e9lev\u00e9.<\/p>\n

\"\"
St\u00e9thoscope, spatule buccale, thermom\u00e8tre clinique : Dispositifs m\u00e9dicaux de cat\u00e9gorie 1 (Image : Rafaelstock - Fotolia.com)<\/figcaption><\/figure>\n

Premi\u00e8re universit\u00e9 de toute l'Europe continentale<\/strong><\/p>\n

Afin de garantir que les produits m\u00e9dicaux, quelle que soit leur classe, puissent \u00eatre accompagn\u00e9s depuis l'id\u00e9e jusqu'au transfert de technologie \u00e0 l'industrie en passant par la recherche et le d\u00e9veloppement, l'\"Institut pour l'ing\u00e9nierie centr\u00e9e sur l'homme HuCE\" de la Haute \u00e9cole sp\u00e9cialis\u00e9e bernoise a fond\u00e9 le groupe \"HuCE-microCert\". Dans un processus unique pour une universit\u00e9, l'\"Institut pour l'ing\u00e9nierie centr\u00e9e sur l'homme HuCE\" de la Haute \u00e9cole sp\u00e9cialis\u00e9e bernoise a \u00e9t\u00e9 la premi\u00e8re universit\u00e9 de toute l'Europe continentale \u00e0 obtenir la certification ISO-13485. La conformit\u00e9 du syst\u00e8me de gestion de la qualit\u00e9 devait \u00eatre prouv\u00e9e dans le cadre d'une proc\u00e9dure d'\u00e9valuation \u00e9labor\u00e9e. Ce certificat fait du HuCE un pr\u00e9cieux partenaire de recherche et de d\u00e9veloppement pour les PME du secteur de la technologie m\u00e9dicale.<\/p>\n

Acc\u00e8s au march\u00e9 de l'UE<\/strong><\/p>\n

Outre une large gamme de services pour les spin-offs, cette certification donne \u00e9galement aux PME et \u00e0 l'industrie un acc\u00e8s plus facile au march\u00e9 europ\u00e9en (marquage CE) et un avantage concurrentiel clair. Cela signifie que la HuCE de BFH peut d\u00e9sormais offrir un ensemble complet (y compris une salle blanche qualifi\u00e9e pour la production de petites s\u00e9ries) et agir comme un partenaire solide dans le domaine de la technologie m\u00e9dicale.<\/p>\n

Source et informations compl\u00e9mentaires : HuCE.bfh.ch<\/a><\/em><\/p>","protected":false},"excerpt":{"rendered":"

La condition pr\u00e9alable \u00e0 la certification ISO-13485 est un syst\u00e8me de management global pour la conception et la fabrication de dispositifs m\u00e9dicaux. En effet, la garantie de la s\u00e9curit\u00e9 et de la sant\u00e9 des patients est centrale, voire imp\u00e9rative, pour les dispositifs m\u00e9dicaux. Des directives strictes, harmonis\u00e9es \u00e0 l'\u00e9chelle europ\u00e9enne, exigent un contr\u00f4le de qualit\u00e9 et une surveillance du march\u00e9 continus. Un syst\u00e8me de gestion de la qualit\u00e9 certifi\u00e9, tel que celui de la norme ISO 13485, est donc essentiel et garantit [...].<\/p>","protected":false},"author":10,"featured_media":746,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[3303],"tags":[3365,3325,3327],"class_list":["post-744","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-qualitaetsmanagement","tag-forschungwissenschaft","tag-managementsysteme","tag-qualitaetsmanagement"],"acf":[],"yoast_head":"\nBFH erlangt ISO-13485 Zertifizierung - MQ Management und Qualit\u00e4t<\/title>\n<meta name=\"description\" content=\"Qualit\u00e4t z\u00e4hlt: Als einzige Hochschule in ganz Kontinentaleuropa hat die Berner Fachhochschule BFH die ISO-13485 Zertifizierung erlangt.\" \/>\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.m-q.ch\/fr\/bfh-obtient-la-certification-iso-13485\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"BFH erlangt ISO-13485 Zertifizierung - 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