A Practical Guide to Planning, Writing, and Reviewing Medical Device Clinical Evaluation Reports 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.

Book Information
ISBN 9780443220630
Author Joy Frestedt
Format Paperback
Page Count 450
Imprint Academic Press Inc
Publisher Elsevier Science Publishing Co Inc
Weight(grams) 450g