{"id":7576,"date":"2020-05-14T12:26:45","date_gmt":"2020-05-14T12:26:45","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=7576"},"modified":"2022-11-14T07:19:18","modified_gmt":"2022-11-14T07:19:18","slug":"medical-device-clinical-evaluation-report-sample-free","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/fr\/medical-device-clinical-evaluation-report-sample-free\/","title":{"rendered":"Exemple de rapport d'\u00e9valuation clinique d'un dispositif m\u00e9dical (gratuit)"},"content":{"rendered":"

Girish Hirpara, consultant en r\u00e9glementation<\/a> sur Kolabtree, fournit un exemple de rapport d'\u00e9valuation clinique pour les dispositifs m\u00e9dicaux \u00e0 utiliser comme mod\u00e8le pour la conformit\u00e9 au MDR. <\/em><\/p>\n

Le rapport d'\u00e9valuation clinique (CER) est un document obligatoire pour les dispositifs m\u00e9dicaux destin\u00e9s \u00e0 \u00eatre mis sur le march\u00e9 de l'UE. Le CER est soumis avec le dossier technique pour r\u00e9pondre aux exigences du MDR de l'UE. S'il est conforme, le dispositif re\u00e7oit une \"marque CE\" qui certifie que le dispositif peut \u00eatre commercialis\u00e9\/vendu en toute s\u00e9curit\u00e9 dans l'UE.<\/p>\n

L'exemple de rapport d'\u00e9valuation clinique documente les r\u00e9sultats de l'\u00e9valuation clinique d'un dispositif m\u00e9dical. Il comprend des informations sur la s\u00e9curit\u00e9 et l'efficacit\u00e9 d'un dispositif, des donn\u00e9es issues d'essais cliniques, une description de la conception technique, des recherches bibliographiques, etc. Le rapport d'\u00e9valuation clinique est sp\u00e9cifique \u00e0 un dispositif et doit \u00eatre mis \u00e0 jour en permanence tout au long du cycle de vie du document, ce qui n\u00e9cessite une maintenance constante.<\/p>\n

Pour aider les fabricants de dispositifs m\u00e9dicaux \u00e0 comprendre le d\u00e9roulement g\u00e9n\u00e9ral et le contenu de la CER, voici un \u00e9chantillon ou un mod\u00e8le de CER GRATUIT que vous pouvez t\u00e9l\u00e9charger. Ce document est destin\u00e9 \u00e0 servir uniquement de r\u00e9f\u00e9rence\/guide pour les fabricants de dispositifs m\u00e9dicaux.<\/p>\n

<\/div>\n

Girish Hirpara is a medical writer with 13 years of clinical recherche<\/a> experience. His expertise spans all aspects of regulatory compliance including ICH-GCP, MEDDEV 2.7.1\/Rev 4, EU MDR 2017\/745, EU IVDR 2017\/746, ISO- 14155, SOPs, and others. Contactez Girish pour un projet ici<\/a>.<\/p>\n

Kolabtree vous aide \u00e0 contacter des r\u00e9dacteurs CER et des consultants en dispositifs m\u00e9dicaux ind\u00e9pendants, \u00e0 la demande. Exploitez un r\u00e9seau mondial d'experts et engagez des sp\u00e9cialistes exp\u00e9riment\u00e9s en dispositifs m\u00e9dicaux qui ont travaill\u00e9 dans des entreprises de premier plan comme Abbott, J&J, Medtronic, Thermo Fisher Scientific, etc. Vous pouvez \u00e9galement travailler avec des chercheurs qui peuvent vous aider \u00e0 comprendre les essais cliniques, la recherche documentaire, la r\u00e9daction m\u00e9dicale, et plus encore.
\nVoir r\u00e9dacteurs freelance de rapports d'\u00e9valuation clinique<\/a>. PUBLIER UN PROJET MAINTENANT<\/a><\/strong><\/p>\n

 <\/p>","protected":false},"excerpt":{"rendered":"

Girish Hirpara, consultant en r\u00e9glementation chez Kolabtree, fournit un exemple de rapport d'\u00e9valuation clinique pour les dispositifs m\u00e9dicaux \u00e0 utiliser comme mod\u00e8le pour la conformit\u00e9 MDR. Le rapport d'\u00e9valuation clinique (CER) est un document obligatoire pour les dispositifs m\u00e9dicaux destin\u00e9s \u00e0 \u00eatre mis sur le march\u00e9 europ\u00e9en. Le CER est soumis en m\u00eame temps que le dossier technique afin de r\u00e9pondre aux exigences du MDR.<\/p>\n

Lire la suite<\/a><\/div>","protected":false},"author":12,"featured_media":7585,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"image","meta":[],"categories":[540],"tags":[],"acf":[],"yoast_head":"\nMedical Device Clinical Evaluation Report Sample (Free)<\/title>\n<meta name=\"description\" content=\"An expert-sourced clinical evaluation report sample for medical device companies preparing for MDR compliance. 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