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. Identifies and explains data analysis for clinical evaluation of medical devicesTeaches readers how to understand and evaluate medical device performance and safety in the context of new regulationsProvides analysis of new clinical evaluation criteria in the context of medical device design as well as in-hospital deployment and servicing INDICE: 1. Preface2. Introduction3. Planning Clinical Evaluations of Medical Devices4. Writing Clinical Evaluation Reports of Medical Devices5. Identifying clinical data6. Appraising clinical data7. Analyzing clinical data8. Integrating post market surveillance systems9. Integrating risk management systems10. Evaluating Risk:Benefit Profiles11. Incorporating post market clinical follow up studies12. Writing Summaries of safety and clinical performance13. Reviewing medical device clinical evaluation reports14. Understanding CER Regulations outside of Europe15. Forecasting CER future directions16. Appendixes17. Index and Definition of Terms

• ISBN: 978-0-443-22063-0
• Editorial: Academic Press
• Encuadernacion: Rústica
• Páginas: 450
• Fecha Publicación: 26/07/2024
• Nº Volúmenes: 1
• Idioma: Inglés