Product details:
| ISBN13: | 9780443220630 |
| ISBN10: | 0443220638 |
| Binding: | Paperback |
| No. of pages: | 450 pages |
| Size: | 235x191 mm |
| Weight: | 450 g |
| Language: | English |
| 700 |
Category:
Planning, Writing and Reviewing Medical Device Clinical and Performance Evaluation Reports (CERs/PERs)
A Practical Guide for the European Union and Other Countries
Publisher: Academic Press
Date of Publication: 1 June 2024
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EUR 142.00
EUR 142.00
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Long description:
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 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:
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
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