{"id":12051,"date":"2023-07-04T14:45:02","date_gmt":"2023-07-04T13:45:02","guid":{"rendered":"http:\/\/lsacademy.com\/?post_type=product&#038;p=12051"},"modified":"2024-02-27T16:26:38","modified_gmt":"2024-02-27T15:26:38","slug":"how-to-write-a-clinical-evaluation-plan-and-report-3","status":"publish","type":"product","link":"https:\/\/lsacademy.com\/it\/product\/how-to-write-a-clinical-evaluation-plan-and-report-3\/","title":{"rendered":"How to Write a Clinical Evaluation Plan and Report"},"content":{"rendered":"<p><span style=\"color: #faa51a;\"><strong>THE TRAINING COURSE IS SOLD OUT<\/strong><\/span><\/p>\n<p><span><strong>The registrations for the next ediiton are open: 13, 15 and 16 May 2024<br \/>\n<a href=\"http:\/\/lsacademy.com\/en\/product\/how-to-write-a-clinical-evaluation-plan-and-report-4\/\">Click here to view all details<\/a><\/strong><\/span><\/p>\n<hr \/>\n<p>Clinical evaluation of a medical device is a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer.<\/p>\n<p>The clinical evaluation plan (CEP) describes how the clinical evaluation will be performed, including objective and measurable clinical benefits, acceptability parameters for the benefit\/risk profile, determination of what will be considered \u2018sufficient clinical data\u2019, what data will be collected and how any knowledge gaps might be addressed.<br \/>\nThe CEP is regularly reviewed and updated and forms the basis of the clinical evaluation report (CER).<br \/>\nThe CER is an important part of the Technical File\/ Design Dossier for a medical device. The medical writer conducts the literature review and compiles the CER with input from design engineers, regulatory specialists, safety scientists and quality experts.<\/p>\n<p>The aim of this course is to better understand what is involved in developing a CEP and writing a CER to Medical Device Regulation (MDR) 2017\/745 standards. The course will focus on the increased requirements of MDR and will cover the clinical evaluation process, literature reviews and post-market surveillance (PMS) and benefit-risk assessment.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>THE TRAINING COURSE IS SOLD OUT The registrations for the next ediiton are open: 13, 15 and 16 May 2024 Click here to view all details Clinical evaluation of a medical device is a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to &hellip; <a href=\"https:\/\/lsacademy.com\/it\/product\/how-to-write-a-clinical-evaluation-plan-and-report-3\/\">Continued<\/a><\/p>\n","protected":false},"featured_media":7259,"template":"","meta":[],"product_brand":[],"product_cat":[46],"product_tag":[],"class_list":["post-12051","product","type-product","status-publish","has-post-thumbnail","course_topics-dispositivi-medici","course_types-corso-online","productgroup-how-to-write-a-clinical-evaluation-report","product_cat-corsi","first","instock","taxable","shipping-taxable","purchasable","product-type-variable"],"_links":{"self":[{"href":"https:\/\/lsacademy.com\/it\/wp-json\/wp\/v2\/product\/12051","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lsacademy.com\/it\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/lsacademy.com\/it\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lsacademy.com\/it\/wp-json\/wp\/v2\/media\/7259"}],"wp:attachment":[{"href":"https:\/\/lsacademy.com\/it\/wp-json\/wp\/v2\/media?parent=12051"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/lsacademy.com\/it\/wp-json\/wp\/v2\/product_brand?post=12051"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/lsacademy.com\/it\/wp-json\/wp\/v2\/product_cat?post=12051"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/lsacademy.com\/it\/wp-json\/wp\/v2\/product_tag?post=12051"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}