{"id":499,"date":"2023-09-08T15:51:36","date_gmt":"2023-09-08T15:51:36","guid":{"rendered":"https:\/\/suite.claudebernard.fr\/?p=499"},"modified":"2026-05-18T17:50:07","modified_gmt":"2026-05-18T15:50:07","slug":"la-base-de-donnees-medicale-claude-bernard-obtient-la-certification-iso-13485","status":"publish","type":"post","link":"https:\/\/suite.claudebernard.fr\/actualites\/la-base-de-donnees-medicale-claude-bernard-obtient-la-certification-iso-13485\/","title":{"rendered":"La base de donn\u00e9es m\u00e9dicale Claude Bernard obtient la certification ISO 13485"},"content":{"rendered":"<p><strong>Boulogne-Billancourt,<\/strong> <strong>le<\/strong> <strong>8<\/strong> <strong>novembre 2022<\/strong><\/p>\n<p><span class=\"text-primary h4\">D\u00e9j\u00e0 agr\u00e9\u00e9e par la Haute Autorit\u00e9 de Sant\u00e9 (HAS) et marqu\u00e9e dispositif CE classe I, la base de donn\u00e9es sur les m\u00e9dicaments Claude Bernard renforce son niveau de conformit\u00e9 en \u00e9tant d\u00e9sormais certifi\u00e9e ISO 13485. Cette nouvelle certification ajoute une garantie suppl\u00e9mentaire \u00e0 l\u2019environnement de confiance et \u00e0 la qualit\u00e9 de services d\u00e9livr\u00e9s par Claude Bernard \u00e0 ses clients et partenaires.<\/span><\/p>\n<h2><span class=\"dgc-text-gradient\">La certification ISO 13485 vient confirmer les exigences de qualit\u00e9 et de s\u00e9curit\u00e9 de la base de donn\u00e9es m\u00e9dicale <a href=\"https:\/\/www.claudebernard.fr\/\"><em>Claude<\/em> <em>Bernard<\/em><\/a><\/span><\/h2>\n<p>L\u2019application de la nouvelle r\u00e9glementation europ\u00e9enne qui encadre la mise sur le march\u00e9 des dispositifs m\u00e9dicaux, est un enjeu d\u2019adaptation majeur pour les entreprises et pour le syst\u00e8me de sant\u00e9 fran\u00e7ais. Ce r\u00e8glement europ\u00e9en renforce consid\u00e9rablement les pr\u00e9requis n\u00e9cessaires \u00e0 l\u2019obtention du marquage CE m\u00e9dical et vient en compl\u00e9ment de l\u2019agr\u00e9ment de la HAS. D\u00e9sormais tous les logiciels d\u2019aide \u00e0 la prescription (LAP) et \u00e0 la dispensation (LAD) sont consid\u00e9r\u00e9s comme dispositif m\u00e9dical (DM), et \u00e0 ce titre la base de donn\u00e9es m\u00e9dicale <a href=\"https:\/\/www.claudebernard.fr\/\"><em>Claude<\/em> <em>Bernard<\/em><\/a> l\u2019est \u00e9galement par les informations qu\u2019elle d\u00e9livre.<\/p>\n<p>En tant que solution d\u2019aide \u00e0 la d\u00e9cision et \u00e0 la prescription pour les professionnels de sant\u00e9, la s\u00e9curit\u00e9 du patient fait naturellement partie des priorit\u00e9s de RESIP, \u00e9diteur de la base <a href=\"https:\/\/www.claudebernard.fr\/\"><em>Claude<\/em> <em>Bernard<\/em>.<\/a> Ainsi, l\u2019entreprise a choisi de mettre en \u0153uvre un Syst\u00e8me de Management de la Qualit\u00e9 (SMQ), bas\u00e9 sur le mod\u00e8le ISO 13485, et de se faire certifier pour satisfaire au mieux les exigences de ses clients, de ses partenaires et du monde m\u00e9dical.<\/p>\n<p><a href=\"https:\/\/www.claudebernard.fr\/\"><em>Claude Bernard<\/em><\/a> vient de recevoir le certificat ISO 13485, de la part de l\u2019AFNOR, dans la cat\u00e9gorie \u00ab recherche et d\u00e9veloppement, conception et fabrication des logiciels d\u2019aide \u00e0 la prescription et \u00e0 la dispensation m\u00e9dicale \u00bb pour la mise en \u0153uvre du Syst\u00e8me de Management de la Qualit\u00e9. Cette certification garantit le respect de la r\u00e9glementation, la prise en compte des exigences clients, mais aussi la ma\u00eetrise de l\u2019activit\u00e9 de base de donn\u00e9es m\u00e9dicale et des risques qui lui sont associ\u00e9s.<\/p>\n<h2><span class=\"dgc-text-gradient\">Une grande avanc\u00e9e vers le marquage CE classe II a<\/span><\/h2>\n<p>\u00ab Notre soci\u00e9t\u00e9 est engag\u00e9e dans une d\u00e9marche qualit\u00e9. Nous nous f\u00e9licitons de l\u2019obtention de la certification ISO 13485 qui atteste que nous sommes aptes \u00e0 produire des bases d\u2019informations m\u00e9dicales de qualit\u00e9 qui r\u00e9pondent aux exigences de s\u00e9curit\u00e9 des patients et des r\u00e9glementations applicables \u00bb, commente <strong>Hammama Bey, Responsable Qualit\u00e9 <\/strong>pour <a href=\"https:\/\/www.claudebernard.fr\/\"><em>Claude Bernard<\/em>.<\/a><\/p>\n<p>\u00ab Un grand merci \u00e0 nos \u00e9quipes engag\u00e9es qui ont permis \u00e0 cette certification de voir le jour. Je suis fier du chemin parcouru, des efforts et de l\u2019implication de chacun au quotidien. Cette certification conforte l\u2019image de conformit\u00e9 et de qualit\u00e9 l\u00e9gitimement attribu\u00e9e \u00e0 <a href=\"https:\/\/www.claudebernard.fr\/\"><em>Claude Bernard<\/em>.<\/a> La dynamique de l\u2019engagement de chacun et la participation active de tous sont les garants de notre r\u00e9ussite d\u2019aujourd\u2019hui et seront l\u2019une des cl\u00e9s de notre succ\u00e8s de demain \u00bb, souligne <strong>Christophe Descamps<\/strong>, <strong>Directeur<\/strong> <strong>de RESIP<\/strong>, <strong>filiale du Groupe Cegedim<\/strong> et \u00e9diteur de la base de donn\u00e9es m\u00e9dicale <a href=\"https:\/\/www.claudebernard.fr\/\"><em>Claude Bernard<\/em>.<\/a><\/p>\n<p>Cette certification souligne que la d\u00e9marche qualit\u00e9 de <a href=\"https:\/\/www.claudebernard.fr\/\"><em>Claude Bernard<\/em><\/a> est bien r\u00e9elle. Les \u00e9quipes continuent d\u2019\u0153uvrer pour l\u2019am\u00e9liorer avec d\u00e9j\u00e0 un prochain cap : le marquage CE de classe II a \u00e0 partir de l\u2019ann\u00e9e prochaine.<\/p>\n<p>&nbsp;<\/p>\n<h3><span class=\"text-primary\">Disclaimer<\/span><\/h3>\n<p><span class=\"text-primary\">Le contenu de la base Claude Bernard doit \u00eatre consid\u00e9r\u00e9 comme un ouvrage scientifique faisant l\u2019objet d\u2019une consultation critique laissant aux professionnels de sant\u00e9 les responsabilit\u00e9s de la prescription, de la dispensation ou de l\u2019administration notamment que le code de sant\u00e9 leur reconna\u00eet. RESIP ne saurait garantir l\u00b4exactitude et l\u00b4exhaustivit\u00e9 des informations contenues au sein de la base Claude Bernard. En effet, bien que les donn\u00e9es et les fonctionnalit\u00e9s de la base Claude Bernard soient \u00e9labor\u00e9es avec extr\u00eamement de vigilance, l\u2019utilisateur doit \u00eatre inform\u00e9 que du fait de la complexit\u00e9 de cette base de donn\u00e9es sur les m\u00e9dicaments et les produits de sant\u00e9, RESIP d\u00e9cline toute responsabilit\u00e9 pour les cons\u00e9quences \u00e9ventuelles pouvant r\u00e9sulter d\u2019une erreur de prescription, de d\u00e9livrance, d\u2019administration ou plus g\u00e9n\u00e9ralement d\u2019utilisation de la base Claude Bernard. Il en r\u00e9sulte que RESIP ne peut \u00eatre tenue pour responsable des cons\u00e9quences d\u00e9coulant de l\u2019utilisation de la base Claude Bernard.<\/span><\/p>\n<p>&nbsp;<\/p>\n<div class=\"card dgc-card\"><div class=\"card-body\"><\/p>\n<h3><span class=\"text-primary\">A propos de la base de donn\u00e9es sur les m\u00e9dicaments et produits de sant\u00e9 Claude Bernard :<\/span><\/h3>\n<p>Filiale du Groupe Cegedim, RESIP (Recherches et Etudes en Syst\u00e8mes Informatiques Professionnels) met \u00e0 la disposition des professionnels de sant\u00e9, la base de donn\u00e9es scientifique d\u2019aide \u00e0 la prescription et \u00e0 la d\u00e9livrance de m\u00e9dicaments Claude Bernard (anciennement BCB). Premi\u00e8re base de donn\u00e9es sur les m\u00e9dicaments et produits de sant\u00e9 agr\u00e9\u00e9e d\u00e8s 2008 par la Haute Autorit\u00e9 de Sant\u00e9 (HAS), Claude Bernard est int\u00e9gr\u00e9e aux logiciels m\u00e9tiers utilis\u00e9s par les professionnels de sant\u00e9 en officine, en cabinet m\u00e9dical, dans les maisons de sant\u00e9 pluridisciplinaires et les \u00e9tablissements de soins : h\u00f4pitaux, cliniques et Ehpad.<\/p>\n<p>La base Claude Bernard compte plus de 300 000 m\u00e9dicaments et produits de sant\u00e9 commercialis\u00e9s r\u00e9f\u00e9renc\u00e9s et mis \u00e0 jour quotidiennement. 150 000 professionnels de sant\u00e9 lui font confiance au quotidien, sur ordinateur, tablette ou application mobile.<\/p>\n<p>Pour plus d\u2019informations <em>: <\/em><a href=\"https:\/\/www.claudebernard.fr\/\">www.claudebernard.fr<\/a><\/p>\n<p><\/div><\/div>\n<p>&nbsp;<\/p>\n<div class=\"card dgc-card\"><div class=\"card-body\"><\/p>\n<h3><span class=\"text-primary\">A propos de Cegedim :<\/span><\/h3>\n<p>Fond\u00e9 en 1969, Cegedim est un Groupe innovant de technologies et de services sp\u00e9cialis\u00e9 dans la gestion des flux num\u00e9riques de l\u2019\u00e9cosyst\u00e8me sant\u00e9 et BtoB, ainsi que dans la conception de logiciels m\u00e9tier destin\u00e9s aux professionnels de sant\u00e9 et de l\u2019assurance. Cegedim compte plus de 5 600 collaborateurs dans plus de 10 pays et a r\u00e9alis\u00e9 un chiffre d\u2019affaires de 525 millions d\u2019euros en 2021. Cegedim SA est cot\u00e9e en bourse \u00e0 Paris (EURONEXT : CGM).<\/p>\n<p>Pour en savoir plus : <a href=\"http:\/\/www.cegedim.fr\/\">www.cegedim.fr<\/a><\/p>\n<p>Et suivez Cegedim sur Twitter : <a href=\"https:\/\/twitter.com\/cegedimgroup\">@CegedimGroup<\/a><u>,<\/u> <a href=\"https:\/\/fr.linkedin.com\/company\/cegedim\">LinkedIn<\/a> et <a href=\"https:\/\/www.facebook.com\/CegedimGroup\/\">Facebook<\/a><\/p>\n<p><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Boulogne-Billancourt, le 8 novembre 2022 D\u00e9j\u00e0 agr\u00e9\u00e9e par la Haute Autorit\u00e9 de Sant\u00e9 (HAS) et marqu\u00e9e dispositif CE classe I, la base de donn\u00e9es sur les m\u00e9dicaments Claude Bernard renforce son niveau de conformit\u00e9 en \u00e9tant d\u00e9sormais certifi\u00e9e ISO 13485. Cette nouvelle certification ajoute une garantie suppl\u00e9mentaire \u00e0 l\u2019environnement de confiance et \u00e0 la qualit\u00e9 [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":13148,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[194],"tags":[],"class_list":["post-499","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-presse"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>La base de donn\u00e9es m\u00e9dicale Claude Bernard obtient la certification ISO 13485 - Claude Bernard<\/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:\/\/suite.claudebernard.fr\/actualites\/la-base-de-donnees-medicale-claude-bernard-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=\"La base de donn\u00e9es m\u00e9dicale Claude Bernard obtient la certification ISO 13485 - Claude Bernard\" \/>\n<meta property=\"og:description\" content=\"Boulogne-Billancourt, le 8 novembre 2022 D\u00e9j\u00e0 agr\u00e9\u00e9e par la Haute Autorit\u00e9 de Sant\u00e9 (HAS) et marqu\u00e9e dispositif CE classe I, la base de donn\u00e9es sur les m\u00e9dicaments Claude Bernard renforce son niveau de conformit\u00e9 en \u00e9tant d\u00e9sormais certifi\u00e9e ISO 13485. 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