Planning, Writing and Reviewing Medical Device Clinical and Performance Evaluation Reports (CERs/PERs)

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ISBN: 9780443220630
Author : Joy Frestedt
Published: 2024
Publisher: Academic Press
Language: English
Format: Paperback / softback
Format: 10.875×8.5

Description

<i>A Practical Guide to Planning, Writing, and Reviewing Medical Device Clinical Evaluation Reports</i> guides readers through clinical data evaluation of medical devices that is in compliance with the EU MDR requirements and other similar regulatory requirements throughout the world. This book brings together knowledge learned as the author constructed hundreds of CERs and taught thousands of learners on how to conduct clinical data evaluations. This book will support training for clinical engineers, clinical evaluation scientists, and experts reviewing medical device CERs, and will help individual writers, teams and companies to develop stronger, more robust CERs.

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