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

A Practical Guide for the European Union and Other Countries

1st Edition - June 1, 2024

Author: Joy Frestedt

Language: English
Paperback ISBN:
9 7 8 - 0 - 4 4 3 - 2 2 0 6 3 - 0
eBook ISBN:
9 7 8 - 0 - 4 4 3 - 2 2 0 6 4 - 7

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 com… Read more

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

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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.