Safety Risk Management for Medical Devices (Paperback, 2 ed)

1. Introduction 2. What Is A Medical Device? 3. Why Do Risk-Management? 4. The Basics 5. Understanding Risk 6. Risk Management Standards 7. Requirements of the Risk Management Process 8. Quality Management System 9. Usability Engineering and Risk Analysis 10. Biocompatibility and Risk Management 11. Lifetime of a Medical Device 12. The BXM Method 13. Risk Management Process 14. Risk Analysis Techniques 15. Safety vs. Reliability 16. Influence of Security on Safety 17. Software Risk Management 18. Hierarchical Multi-Level FMEA 19. Risk Estimation 20. Risk Controls 21. Verification of Risk Controls 22. Application of Risk Acceptance Criteria 23. Risk Assessment and Control Table (RACT) 24. On Testing 25. Benefit-Risk Analysis 26. Risk Management Review 27. Production and Post-Production Activities 28. Traceability 29. Risk Management for Clinical Investigations 30. Risk Management for Legacy Devices 31. Basic Safety and Essential Performance 32. Relationship between ISO 14971 and other Standards 33. Risk Management Process Metrics 34. Risk Management and Product Development Process 35. Axioms 36. Special Topics 37. Critical Thinking and Risk Management 38. Advice and Wisdom 39. References 40. Risk Management for Suppliers

Appendix A. Glossary? B. Templates C. Example Device ? Vivio D. NBRG Consensus Paper