{"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\/it\/medical-device-clinical-evaluation-report-sample-free\/","title":{"rendered":"Esempio di rapporto di valutazione clinica dei dispositivi medici (gratuito)"},"content":{"rendered":"<p><em>Girish Hirpara, <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-writing\">consulente normativo<\/a> su Kolabtree, fornisce un esempio di rapporto di valutazione clinica per i dispositivi medici da usare come modello per la conformit\u00e0 MDR. <\/em><\/p>\n<p>Il rapporto di valutazione clinica (CER) \u00e8 un documento obbligatorio per i dispositivi medici che devono essere immessi nel mercato UE. Il CER viene presentato insieme al fascicolo tecnico per soddisfare i requisiti MDR dell'UE. Se conforme, il dispositivo riceve un \"marchio CE\" che certifica che il dispositivo pu\u00f2 essere commercializzato\/venduto in sicurezza nell'UE.<\/p>\n<p>L'esempio di rapporto di valutazione clinica documenta i risultati della valutazione clinica fatta per un dispositivo medico. Include informazioni sulla sicurezza e l'efficacia di un dispositivo, dati da studi clinici, descrizione del progetto tecnico, ricerche nella letteratura e altro ancora. Il CER \u00e8 specifico per un dispositivo e deve essere continuamente aggiornato per tutto il ciclo di vita del documento, e quindi ha bisogno di una manutenzione costante.<\/p>\n<p>Per aiutare i produttori di dispositivi medici a capire il flusso generale e il contenuto del CER, ecco un campione GRATUITO o un modello CER che potete scaricare. Questo documento \u00e8 destinato a servire solo come riferimento\/guida per i produttori di dispositivi medici.<\/p>\n<div class='mailmunch-forms-short-code mailmunch-forms-widget-888372' style='display: none !important;'><\/div>\n<p>Girish Hirpara is a medical writer with 13 years of clinical <a href=\"https:\/\/www.kolabtree.com\/blog\/it\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">ricerca<\/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. <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/girish-hirpara\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERSample\">Contatta Girish per un progetto qui<\/a>.<\/p>\n<p>Kolabtree ti aiuta a contattare scrittori freelance CER e consulenti di dispositivi medici, su richiesta. Attingi a una rete globale di esperti e assumi specialisti di dispositivi medici esperti che hanno lavorato in aziende leader come Abbott, J&amp;J, Medtronic, Thermo Fisher Scientific e altre. Puoi anche lavorare con ricercatori che possono aiutarti a capire con studi clinici, ricerca di letteratura, scrittura medica e altro.<br \/>\nVedi <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-reports-cer\">scrittori freelance di relazioni di valutazione clinica<\/a>. <strong><a href=\"https:\/\/www.kolabtree.com\/create-project\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERSample\">PUBBLICA UN PROGETTO ORA<\/a><\/strong><\/p>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>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<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/it\/medical-device-clinical-evaluation-report-sample-free\/\" title=\"Per saperne di pi\u00f9\">Per saperne di pi\u00f9<\/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":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.1 (Yoast SEO v20.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Medical 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. Use this referenence template for free.\" \/>\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.kolabtree.com\/blog\/it\/medical-device-clinical-evaluation-report-sample-free\/\" \/>\n<meta property=\"og:locale\" content=\"it_IT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical Device Clinical Evaluation Report Sample (Free)\" \/>\n<meta property=\"og:description\" content=\"An expert-sourced clinical evaluation report sample for medical device companies preparing for MDR compliance. Use this referenence template for free.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/it\/medical-device-clinical-evaluation-report-sample-free\/\" \/>\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=\"Scritto da\" \/>\n\t<meta name=\"twitter:data1\" content=\"Ramya Sriram\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tempo di lettura stimato\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minuti\" \/>\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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