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

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

Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.

• Biotecnologia
• Farmacologia
• Pesquisa médica
• Biologia, ciências da vida
• Modelagem computacional e simulação
• Engenharia biomédica

Medical device evaluation; clinical evaluation; post-market surveillance; CER; risk management; clinical data identification; clinical data appraisal; clinical data analysis; device vigilance; safety; performance