Planning, Writing and Reviewing Medical Device Clinical and Performance Evaluation Reports (Cers/Pers): A Practical Guide for the European Union and O

ISBN-13: 9780443220630 / Angielski

Joy Frestedt

Spis treści

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