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.
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Table of Contents
1. Preface2. Introduction
3. Planning Clinical Evaluations of Medical Devices
4. Writing Clinical Evaluation Reports of Medical Devices
5. Identifying clinical data
6. Appraising clinical data
7. Analyzing clinical data
8. Integrating post market surveillance systems
9. Integrating risk management systems
10. Evaluating Risk:Benefit Profiles
11. Incorporating post market clinical follow up studies
12. Writing Summaries of safety and clinical performance
13. Reviewing medical device clinical evaluation reports
14. Understanding CER Regulations outside of Europe
15. Forecasting CER future directions
16. Appendixes
17. Index and Definition of Terms
