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

A Practical Guide for the European Union and Other Countries

Joy Frestedt

• Publisher: Academic Press
• Year: 2024
• eBook ISBN: 9780443220647
• Edition: 0
• Topic: Medicine
• Subtopic: Medical Theory, Practice & Reference

A Practical Guide to Planning, Writing, and Reviewing Medical Device Clinical Evaluation Reports guides readers through clinical data evaluation of medical devices, 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. - Identifies and explains data analysis for clinical evaluation of medical devices - Teaches readers how to understand and evaluate medical device performance and safety in the context of new regulations - Provides analysis of new clinical evaluation criteria in the context of medical device design as well as in-hospital deployment and servicing

Table of contents

• Title of Book
• Cover image
• Title page
• Table of Contents
• Copyright
• List of figures
• List of tables
• List of boxes
• Preface
• Chapter 1 Introduction
• Chapter 2 Planning clinical/performance evaluations
• Chapter 3 Identifying clinical/performance data
• Chapter 4 Appraising clinical/performance data
• Chapter 5 Analyzing clinical/performance data
• Chapter 6 Establishing clinical benefit-risk ratios
• Chapter 7 Writing clinical/performance evaluation documents
• Chapter 8 Writing safety and performance summary documents
• Chapter 9 Reviewing clinical/performance evaluation documents
• Chapter 10 Integrating clinical evaluation, postmarket surveillance and risk management systems
• Chapter 11 Understanding clinical evaluation regulations outside of Europe
• Chapter 12 Forecasting clinical evaluation future directions
• Appendix A. Example regulatory evolution timeline
• Appendix B. MEDDEV guidance list
• Appendix C. Medical Device Coordinating Group endorsed guidance documents
• Appendix D. Appraisal question examples
• Appendix E. Notified Body clinical evaluation checklist
• Appendix F. Clinical evaluation plan/performance evaluation plan requirements checklist
• Appendix G. Clinical evaluation standard operating procedure example 1 (short)
• Appendix H. Clinical evaluation standard operating procedure example 2 (long)
• Appendix I. Clinical evaluation work instruction example
• Appendix J. Kick off meeting agenda/minutes/slides
• Appendix K. Clinical Evaluation Plan Template
• Appendix L. Clinical evaluation report template
• Appendix M. Clinical data requirements checklists
• Appendix N. Declaration of Interest template
• Appendix O. Summary of safety and clinical performance/summary of safety and performance template
• Appendix P. Benefit-risk ratio checklist
• Appendix Q. Clinical evaluation/performance evaluation strategy checklist
• Appendix R. Clinical data requirements matrix
• Appendix S. Reference list of regulatory jurisdictions
• Appendix T. Answers to review questions
• Index