{"id":6878,"date":"2020-02-07T13:14:07","date_gmt":"2020-02-07T13:14:07","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=6878"},"modified":"2021-04-06T12:36:40","modified_gmt":"2021-04-06T12:36:40","slug":"writing-a-clinical-evaluation-report-5-quick-tips","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/it\/writing-a-clinical-evaluation-report-5-quick-tips\/","title":{"rendered":"Scrivere un rapporto di valutazione clinica: 5 suggerimenti rapidi"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_45_1 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\">Indice dei contenuti<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" area-label=\"ez-toc-toggle-icon-1\"><label for=\"item-69f1d687f0b72\" aria-label=\"Table of Content\"><span style=\"display: flex;align-items: center;width: 35px;height: 30px;justify-content: center;direction:ltr;\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewbox=\"0 0 24 24\" version=\"1.2\" baseprofile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/label><input  type=\"checkbox\" id=\"item-69f1d687f0b72\"><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.kolabtree.com\/blog\/it\/writing-a-clinical-evaluation-report-5-quick-tips\/#1_Define_a_CER_protocol_and_strategy\" title=\"1. Definire un protocollo e una strategia CER\">1. Definire un protocollo e una strategia CER<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/it\/writing-a-clinical-evaluation-report-5-quick-tips\/#2_Demonstrate_equivalence\" title=\"2. Dimostrare l&#039;equivalenza\">2. Dimostrare l'equivalenza<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/it\/writing-a-clinical-evaluation-report-5-quick-tips\/#3_Evaluate_literature_review_data\" title=\"3. Valutare i dati della revisione della letteratura\">3. Valutare i dati della revisione della letteratura<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/it\/writing-a-clinical-evaluation-report-5-quick-tips\/#4_Determine_requirement_for_clinical_investigation\" title=\"4. Determinare i requisiti per l&#039;indagine clinica\">4. Determinare i requisiti per l'indagine clinica<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/it\/writing-a-clinical-evaluation-report-5-quick-tips\/#5_Monitor_post-market_activities\" title=\"5. Monitorare le attivit\u00e0 post-commercializzazione\">5. Monitorare le attivit\u00e0 post-commercializzazione<\/a><\/li><\/ul><\/nav><\/div>\n<p><em>Sophie Laurenson, <a href=\"https:\/\/www.kolabtree.com\/blog\/it\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">assistenza sanitaria<\/a> &amp; technology innovator\u00a0on Kolabtree, shares 5 tips for writing a clinical evaluation report and defining a CER strategy.<\/em><\/p>\n<p>La MDR dell'UE ha avuto un impatto significativo sul modo in cui i dispositivi medici sono regolati in Europa. Come parte della conformit\u00e0 normativa, i produttori di dispositivi medici devono creare e mantenere un rapporto di valutazione clinica (CER), un documento essenziale per il marchio CE. Ecco i consigli degli esperti su cosa prendere in considerazione per definire una solida strategia CER.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"1_Define_a_CER_protocol_and_strategy\"><\/span>1. Definire un protocollo e una strategia CER<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Identificare i requisiti essenziali (requisiti di sicurezza e prestazione nella MDR) che devono essere supportati da prove cliniche. Definire le metriche relative alle prestazioni, alla sicurezza e agli endpoint rischio\/beneficio.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"2_Demonstrate_equivalence\"><\/span><strong>2. Dimostrare l'equivalenza<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>L'equivalenza \u00e8 determinata sulla base del confronto tra un dispositivo medico e altri dispositivi preesistenti e simili con marchio CE. La dimostrazione di equivalenza \u00e8 valutata su parametri rilevanti che sono definiti dal produttore. Il razionale per l'equivalenza deve essere completamente spiegato nel CER. I criteri di equivalenza sono diventati complessi e rigorosi, con collegamenti pi\u00f9 forti ai Requisiti Essenziali. \u00c8 fondamentale evitare l'errore comune di selezionare dispositivi equivalenti che non sono rilevanti per il vostro prodotto. I dati documentati devono essere identificati e analizzati per ogni dispositivo equivalente e per le differenze tra i dispositivi.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"3_Evaluate_literature_review_data\"><\/span><strong>3. Valutare i dati della revisione della letteratura<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"_04xlpA direction-ltr align-start para-style-body\">Se l'equivalenza pu\u00f2 essere dimostrata adeguatamente, i dati clinici estratti dalla letteratura su studi precedenti sono uno strumento prezioso nella compilazione di una CER. Tuttavia, \u00e8 fondamentale che le indagini della letteratura siano condotte in un processo sistematico:<\/p>\n<p>- Preparare un protocollo completo per la revisione della letteratura,<br \/>\n- Definire input e parametri come database, termini di ricerca e criteri di esclusione (lingue, tipo di studio \/ disegno, impostazione dello studio, endpoint),<br \/>\n- Definire i criteri di sicurezza e prestazione richiesti in base ai prodotti equivalenti e all'analisi dei rischi,<br \/>\n- Raccogliere sistematicamente articoli rilevanti da diverse fonti di dati,<br \/>\n- Analizzare i dati utilizzando un metodo oggettivo come un quadro di riferimento e utilizzando pi\u00f9 revisori, e,<br \/>\n- Documentare le conclusioni della valutazione della letteratura per l'inclusione nel documento CER.<\/p>\n<p><strong>Leggi anche: <a href=\"https:\/\/www.kolabtree.com\/blog\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Come assumere uno scrittore di rapporti di valutazione clinica per il tuo dispositivo medico<\/a>\u00a0<\/strong><\/p>\n<h2><span class=\"ez-toc-section\" id=\"4_Determine_requirement_for_clinical_investigation\"><\/span>4. Determinare i requisiti per l'indagine clinica<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"_04xlpA direction-ltr align-start para-style-body\">Il requisito di un'indagine clinica \u00e8 determinato dal profilo di rischio del dispositivo. I dispositivi ad alto rischio e di classe III devono essere sottoposti a un'indagine clinica. Anche la novit\u00e0 \u00e8 un fattore determinante, e i dispositivi basati su tecnologie innovative o per un nuovo uso previsto richiedono un'indagine clinica. L'evidenza clinica disponibile deve riguardare tutti gli ER pertinenti. Questo pu\u00f2 essere garantito condividendo il Piano di Indagine Clinica (CIP) con l'NB pertinente prima dell'implementazione.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"5_Monitor_post-market_activities\"><\/span>5. <strong>Monitorare le attivit\u00e0 post-commercializzazione<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"_04xlpA direction-ltr align-start para-style-body\">Secondo la MDR, le attivit\u00e0 PMS devono essere adeguatamente pianificate e documentate nella CER. Anche i processi di valutazione dei dati clinici in corso e di aggiornamento delle CER devono essere documentati. Per garantire che il CER rimanga rilevante per tutto il ciclo di vita del prodotto, deve essere aggiornato regolarmente attraverso un processo documentato. Questo include la valutazione dei dati e la valutazione della rilevanza di tutti i dispositivi equivalenti.<\/p>\n<p><strong>Hai bisogno di aiuto per scrivere un rapporto di valutazione clinica? Assumi un freelance <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report-cer?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Scrittore di CER per dispositivi medici<\/a> su Kolabtree. \u00c8 gratuito pubblicare il tuo progetto e ottenere preventivi.<\/strong><\/p>\n<p>Esperti correlati:<\/p>\n<p><strong><a href=\"https:\/\/www.kolabtree.com\/industry\/medical-device?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Consulenti di dispositivi medici<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Scrittore medico freelance<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report-cer?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Scrittore freelance CER<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device-regulations--mdr-?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Consulenti MDR dell'UE<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/fda-submissions?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Presentazioni FDA<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/services\/literature-search?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Esperti di ricerca della letteratura<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-compliance?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Esperti di conformit\u00e0 normativa<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-trials?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Esperto in studi clinici<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Scrittori normativi<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/post-market-surveillance?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Consulenti PMS<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/country\/india\/subject\/post-market-clinical-followup?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Consulenti PMCF<\/a>\u00a0|<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/biostatistics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">\u00a0Esperti di biostatistica<\/a>\u00a0|<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/product-development?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">\u00a0Esperto di sviluppo del prodotto\u00a0<\/a><\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>Sophie Laurenson, healthcare &amp; technology innovator\u00a0on Kolabtree, shares 5 tips for writing a clinical evaluation report and defining a CER strategy. The EU MDR has significantly impacted the way medical devices are regulated in Europe. As part of regulatory compliance, medical device manufacturers need to create and maintain a Clinical Evaluation Report (CER), a document<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/it\/writing-a-clinical-evaluation-report-5-quick-tips\/\" title=\"Per saperne di pi\u00f9\">Per saperne di pi\u00f9<\/a><\/div>","protected":false},"author":12,"featured_media":6882,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[247,443,540],"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>Writing a Clinical Evaluation Report: 5 Quick Tips - The Kolabtree Blog<\/title>\n<meta name=\"description\" content=\"Quick tips on writing a clinical evaluation report (CER) for medical device compliance with the EU MDR.\" \/>\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\/redaccion-de-un-informe-de-evaluacion-clinica-5-consejos-rapidos\/\" \/>\n<meta property=\"og:locale\" content=\"it_IT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Writing a Clinical Evaluation Report: 5 Quick Tips\" \/>\n<meta property=\"og:description\" content=\"Quick tips on writing a clinical evaluation report (CER) for medical device compliance with the EU MDR.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/it\/redaccion-de-un-informe-de-evaluacion-clinica-5-consejos-rapidos\/\" \/>\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=\"2020-02-07T13:14:07+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-04-06T12:36:40+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/02\/writing-a-clinical-evaluation-report.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1280\" \/>\n\t<meta property=\"og:image:height\" content=\"853\" \/>\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=\"3 minuti\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Writing a Clinical Evaluation Report: 5 Quick Tips - 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