Planning, Writing and Reviewing Medical Device Clinical and Performance Evaluation Reports (CERs/PERs)
A Practical Guide for the European Union and Other Countries

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.

1. Preface
2. 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

Joy Frestedt Is the President and CEO for Frestedt Incorporated, a consulting group of over 70 experts providing services in broad CRQE areas of clinical trial development and execution, as well as US and international regulatory compliance, management of corporate quality systems, and biomedical engineering. She has managed clinical research, regulatory affairs, and quality systems for more than 40 years and has published more than 100 manuscripts, as well as book chapters. With a PhD in Pathobiology from the University of Minnesota Medical School, her experience includes designing, conducting and overseeing clinical trials as well as negotiating regulatory submissions and developing quality systems for companies like the University of Minnesota, Orphan Medical, Astra Zeneca Pharmaceuticals, Johnson and Johnson, Medtronic, and Mayo Clinical Trial Services.