Joy Frestedt,
Joy (President and CEO, Frestedt Incorporated, St. Louis Park, MN, USA) Frestedt
Elsevier Science
e druk, 2024
9780443220630
Planning, Writing and Reviewing Medical Device Clinical and Performance Evaluation Reports (CERs/PERs)
A Practical Guide for the European Union and Other Countries
Specificaties
Paperback, blz.
|
Engels
Elsevier Science |
e druk, 2024
ISBN13: 9780443220630
Rubricering
Levertijd ongeveer 8 werkdagen
Samenvatting
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.
Specificaties
Inhoudsopgave
1. Preface<br>2. Introduction<br>3. Planning Clinical Evaluations of Medical Devices<br>4. Writing Clinical Evaluation Reports of Medical Devices<br>5. Identifying clinical data<br>6. Appraising clinical data<br>7. Analyzing clinical data<br>8. Integrating post market surveillance systems<br>9. Integrating risk management systems<br>10. Evaluating Risk:Benefit Profiles<br>11. Incorporating post market clinical follow up studies<br>12. Writing Summaries of safety and clinical performance<br>13. Reviewing medical device clinical evaluation reports<br>14. Understanding CER Regulations outside of Europe<br>15. Forecasting CER future directions<br>16. Appendixes<br>17. Index and Definition of Terms