Safety Risk Management for Medical Devices

ISBN-13: 9780128130988 / Angielski / Miękka / 2018 / 424 str.

Bijan Elahi

Spis treści

1. Why do risk management? 2. Fundamentals of risk management 3. Understanding risk 4. Risk Management standards 5. Requirements of a compliant risk management process 6. Quality management system 7. Usability engineering and risk management 8. Biocompatibility and risk management 9. Risk management process 10. Risk analysis techniques 11. Safety vs. reliability 12. Influence of security on safety 13. Software risk management 14. Integration of risk analyses 15. Risk estimation 16. Risk controls 17. Risk evaluation 18. Risk assessment and control table 19. On testing 20. Verification of risk controls 21. Benefit-risk analysis 22. Production and post-production monitoring 23. Traceability 24. Risk management for clinical investigations 25. Risk management for legacy devices 26. Relationship between ISO 14971 and other safety standards 27. Risk management process metrics 28. Risk management and product development process 29. Critical thinking and risk management 30. Advice and wisdom