{"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\/pt\/medical-device-clinical-evaluation-report-sample-free\/","title":{"rendered":"Relat\u00f3rio de Avalia\u00e7\u00e3o Cl\u00ednica de Dispositivos M\u00e9dicos Amostra (Gr\u00e1tis)"},"content":{"rendered":"

Girish Hirpara, consultor de regulamenta\u00e7\u00e3o<\/a> em Kolabtree, fornece uma amostra de relat\u00f3rio de avalia\u00e7\u00e3o cl\u00ednica para dispositivos m\u00e9dicos a ser usada como modelo para conformidade com a MDR. <\/em><\/p>\n

O relat\u00f3rio de avalia\u00e7\u00e3o cl\u00ednica (CER) \u00e9 um documento obrigat\u00f3rio para dispositivos m\u00e9dicos que devem ser colocados no mercado da UE. O CER \u00e9 apresentado junto com o arquivo t\u00e9cnico para atender \u00e0s exig\u00eancias do MDR da UE. Se estiver em conformidade, o dispositivo recebe uma \"Marca CE\" que certifica que o dispositivo pode ser comercializado\/vendido com seguran\u00e7a na UE.<\/p>\n

A amostra do relat\u00f3rio de avalia\u00e7\u00e3o cl\u00ednica documenta os resultados da avalia\u00e7\u00e3o cl\u00ednica feita para um dispositivo m\u00e9dico. Ele inclui informa\u00e7\u00f5es sobre a seguran\u00e7a e a efic\u00e1cia de um dispositivo, dados de ensaios cl\u00ednicos, descri\u00e7\u00e3o t\u00e9cnica do projeto, pesquisas bibliogr\u00e1ficas e muito mais. O CER \u00e9 espec\u00edfico para um dispositivo e tem que ser continuamente atualizado durante todo o ciclo de vida do documento e, portanto, precisa de manuten\u00e7\u00e3o constante.<\/p>\n

Para ajudar os fabricantes de dispositivos m\u00e9dicos a entender o fluxo geral e o conte\u00fado do CER, aqui est\u00e1 uma amostra GRATUITA ou modelo CER que voc\u00ea pode baixar. Este documento destina-se a servir apenas como refer\u00eancia\/orienta\u00e7\u00e3o para os fabricantes de produtos m\u00e9dicos.<\/p>\n

<\/div>\n

Girish Hirpara is a medical writer with 13 years of clinical pesquisa<\/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. Entre em contato com o Girish para um projeto aqui<\/a>.<\/p>\n

A Kolabtree ajuda voc\u00ea a entrar em contato com escritores freelancer CER e consultores de dispositivos m\u00e9dicos, sob demanda. Entre em uma rede global de especialistas e contrate especialistas em dispositivos m\u00e9dicos experientes que j\u00e1 trabalharam em empresas de ponta como Abbott, J&J, Medtronic, Thermo Fisher Scientific, e muito mais. Voc\u00ea tamb\u00e9m pode trabalhar com pesquisadores que podem ajud\u00e1-lo a entender com ensaios cl\u00ednicos, pesquisa bibliogr\u00e1fica, reda\u00e7\u00e3o m\u00e9dica e muito mais.
\nVer redatores de relat\u00f3rios de avalia\u00e7\u00e3o cl\u00ednica freelance<\/a>. POSTAR UM PROJETO AGORA<\/a><\/strong><\/p>\n

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

Girish Hirpara, regulatory consultant on Kolabtree, provides a clinical evaluation report sample for medical devices to use as a template for MDR compliance. The clinical evaluation report (CER) is a mandatory document for medical devices that are to be placed in the EU market. The CER is submitted along with the technical file to meet<\/p>\n

Leia mais<\/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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