{"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\/es\/dispositivo-medico-evaluacion-clinica-informe-sin-muestras\/","title":{"rendered":"Ejemplo de informe de evaluaci\u00f3n cl\u00ednica de un dispositivo m\u00e9dico (gratuito)"},"content":{"rendered":"

Girish Hirpara, consultor de reglamentaci\u00f3n<\/a> en Kolabtree, ofrece un ejemplo de informe de evaluaci\u00f3n cl\u00ednica de productos sanitarios para utilizarlo como plantilla para el cumplimiento del MDR. <\/em><\/p>\n

El informe de evaluaci\u00f3n cl\u00ednica (CER) es un documento obligatorio para los productos sanitarios que se van a comercializar en la UE. El RCE se presenta junto con el expediente t\u00e9cnico para cumplir los requisitos del MDR de la UE. Si es conforme, el producto recibe el \"marcado CE\", que certifica que el producto puede comercializarse o venderse con seguridad en la UE.<\/p>\n

El modelo de informe de evaluaci\u00f3n cl\u00ednica documenta los resultados de la evaluaci\u00f3n cl\u00ednica realizada para un producto sanitario. Incluye informaci\u00f3n sobre la seguridad y la eficacia de un dispositivo, datos de ensayos cl\u00ednicos, descripci\u00f3n del dise\u00f1o t\u00e9cnico, b\u00fasquedas bibliogr\u00e1ficas y mucho m\u00e1s. El informe de evaluaci\u00f3n cl\u00ednica es espec\u00edfico de un dispositivo y debe actualizarse continuamente a lo largo del ciclo de vida del documento, por lo que necesita un mantenimiento constante.<\/p>\n

Para ayudar a los fabricantes de productos sanitarios a entender el flujo general y el contenido de la RCE, aqu\u00ed tiene una muestra o plantilla de RCE GRATUITA que puede descargar. Este documento est\u00e1 destinado a servir \u00fanicamente como referencia\/gu\u00eda para los fabricantes de productos sanitarios.<\/p>\n

<\/div>\n

Girish Hirpara is a medical writer with 13 years of clinical investigaci\u00f3n<\/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. Contacte con Girish para un proyecto aqu\u00ed<\/a>.<\/p>\n

Kolabtree le ayuda a ponerse en contacto con redactores aut\u00f3nomos de RCE y consultores de dispositivos m\u00e9dicos, bajo demanda. Acceda a una red global de expertos y contrate a especialistas en productos sanitarios con experiencia que han trabajado en empresas de primera l\u00ednea como Abbott, J&J, Medtronic, Thermo Fisher Scientific, etc. Tambi\u00e9n puede trabajar con investigadores que pueden ayudarle a entender con los ensayos cl\u00ednicos, la b\u00fasqueda de literatura, la escritura m\u00e9dica, y m\u00e1s.
\nVer redactores aut\u00f3nomos de informes de evaluaci\u00f3n cl\u00ednica<\/a>. PUBLICAR UN PROYECTO AHORA<\/a><\/strong><\/p>\n

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

Girish Hirpara, consultor en materia de reglamentaci\u00f3n en Kolabtree, ofrece un ejemplo de informe de evaluaci\u00f3n cl\u00ednica de productos sanitarios para utilizarlo como plantilla para el cumplimiento del MDR. El informe de evaluaci\u00f3n cl\u00ednica (CER) es un documento obligatorio para los productos sanitarios que se van a comercializar en la UE. El CER se presenta junto con el expediente t\u00e9cnico para cumplir<\/p>\n

Leer m\u00e1s<\/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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Use this referenence template for free.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/es\/dispositivo-medico-evaluacion-clinica-informe-sin-muestras\/\" \/>\n<meta property=\"og:site_name\" content=\"The Kolabtree Blog\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/kolabtree\" \/>\n<meta property=\"article:published_time\" content=\"2020-05-14T12:26:45+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-11-14T07:19:18+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/medical-device-CER-sample.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\n\t<meta property=\"og:image:height\" content=\"628\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Ramya Sriram\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:site\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"Ramya Sriram\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutos\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Medical Device Clinical Evaluation Report Sample (Free)","description":"An expert-sourced clinical evaluation report sample for medical device companies preparing for MDR compliance. 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