Safety Risk Management for Medical Devices, Second Edition teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. Focusing exclusively on safety risk assessment practices required in the MedTech sector, the book outlines sensible, easily comprehensible, state-of the-art methodologies that are rooted in current industry best practices, addressing safety risk management of medical devices, thus making it useful for those in the MedTech sector who are responsible for safety risk management or need to understand risk management, including design engineers, product engineers, development engineers, software engineers, Quality assurance and regulatory affairs.
Graduate-level engineering students with an interest in medical devices will also benefit from this book. The new edition has been fully updated to reflect the state-of-the-art in this fast changing field. It offers guidance on developing and commercializing medical devices in line with the most current international standards and regulations.
1. Chapter 1 Introduction - p. 1 2. Chapter 2 What Is a Medical Device? - p. 5 3. Chapter 3 Why Do Risk-Management? - p. 11 4. Chapter 4 The Basics - p. 17 5. Chapter 5 Understanding Risk - p. 27 6. Chapter 6 Risk Management Standards - p. 35 7. Chapter 7 Requirements of the Risk Management Process - p. 39 8. Chapter 8 Quality Management System - p. 45 9. Chapter 9 Usability Engineering and Risk Analysis - p. 47 10. Chapter 10 Biocompatibility and Risk Management - p. 59 11. Chapter 11 Influence of Security on Safety - p. 63 12. Chapter 12 The BXM Method - p. 67 13. Chapter 13 Risk Management Process - p. 71 14. Chapter 14 Risk Analysis Techniques - p. 89 15. Chapter 15 Software Risk Management - p. 155 16. Chapter 16 Integration of Risk Analysis - p. 183 17. Chapter 17 Risk Estimation - p. 189 18. Chapter 18 Risk Controls - p. 199 19. Chapter 19 Verification of Risk Controls - p. 207 20. Chapter 20 On Testing - p. 213 21. Chapter 21 Risk Evaluation - p. 219 22. Chapter 22 Risk Assessment and Control Table - p. 225 23. Chapter 23 Benefit-Risk Analysis - p. 231 24. Chapter 24 Risk Management Review - p. 239 25. Chapter 25 Production and Post-Production Activities - p. 241 26. Chapter 26 Traceability - p. 269 27. Chapter 27 Lifetime of a Medical Device - p. 271 28. Chapter 28 Safety Versus Reliability - p. 273 29. Chapter 29 Risk Management for System of Systems - p. 275 30. Chapter 30 Risk Management for Clinical Investigations - p. 281 31. Chapter 31 Risk Management for Legacy Devices - p. 291 32. Chapter 32 Risk Management for Combination Medical Devices - p. 293 33. Chapter 33 Basic Safety and Essential Performance - p. 297 34. Chapter 34 Relationship between ISO 14971 and other Standards - p. 299 35. Chapter 35 Risk Management Process Metrics - p. 305 36. Chapter 36 Risk Management and Product Development Process - p. 307 37. Chapter 37 Risk Management for Suppliers - p. 313 38. Chapter 38 Axioms - p. 317 39. Chapter 39 Special Topics - p. 319 40. Chapter 40 Critical Thinking and Risk Management - p. 325 41. Chapter 41 Advice and Wisdom - p. 329 42. Appendix A Glossary - p. 333 43. Appendix B Templates - p. 339 44. Appendix C Example Device – Vivio - p. 375 45. Appendix D Useful References - p. 507 46. References - p. 509 47. Index - p. 511
Safety Risk Management for Medical Devices, Second Edition teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. Focusing exclusively on safety risk assessment practices required in the MedTech sector, the book outlines sensible, easily comprehensible, state-of the-art methodologies that are rooted in current industry best practices, addressing safety risk management of medical devices, thus making it useful for those in the MedTech sector who are responsible for safety risk management or need to understand risk management, including design engineers, product engineers, development engineers, software engineers, Quality assurance and regulatory affairs.
Graduate-level engineering students with an interest in medical devices will also benefit from this book. The new edition has been fully updated to reflect the state-of-the-art in this fast changing field. It offers guidance on developing and commercializing medical devices in line with the most current international standards and regulations.
1. Chapter 1 Introduction - p. 1 2. Chapter 2 What Is a Medical Device? - p. 5 3. Chapter 3 Why Do Risk-Management? - p. 11 4. Chapter 4 The Basics - p. 17 5. Chapter 5 Understanding Risk - p. 27 6. Chapter 6 Risk Management Standards - p. 35 7. Chapter 7 Requirements of the Risk Management Process - p. 39 8. Chapter 8 Quality Management System - p. 45 9. Chapter 9 Usability Engineering and Risk Analysis - p. 47 10. Chapter 10 Biocompatibility and Risk Management - p. 59 11. Chapter 11 Influence of Security on Safety - p. 63 12. Chapter 12 The BXM Method - p. 67 13. Chapter 13 Risk Management Process - p. 71 14. Chapter 14 Risk Analysis Techniques - p. 89 15. Chapter 15 Software Risk Management - p. 155 16. Chapter 16 Integration of Risk Analysis - p. 183 17. Chapter 17 Risk Estimation - p. 189 18. Chapter 18 Risk Controls - p. 199 19. Chapter 19 Verification of Risk Controls - p. 207 20. Chapter 20 On Testing - p. 213 21. Chapter 21 Risk Evaluation - p. 219 22. Chapter 22 Risk Assessment and Control Table - p. 225 23. Chapter 23 Benefit-Risk Analysis - p. 231 24. Chapter 24 Risk Management Review - p. 239 25. Chapter 25 Production and Post-Production Activities - p. 241 26. Chapter 26 Traceability - p. 269 27. Chapter 27 Lifetime of a Medical Device - p. 271 28. Chapter 28 Safety Versus Reliability - p. 273 29. Chapter 29 Risk Management for System of Systems - p. 275 30. Chapter 30 Risk Management for Clinical Investigations - p. 281 31. Chapter 31 Risk Management for Legacy Devices - p. 291 32. Chapter 32 Risk Management for Combination Medical Devices - p. 293 33. Chapter 33 Basic Safety and Essential Performance - p. 297 34. Chapter 34 Relationship between ISO 14971 and other Standards - p. 299 35. Chapter 35 Risk Management Process Metrics - p. 305 36. Chapter 36 Risk Management and Product Development Process - p. 307 37. Chapter 37 Risk Management for Suppliers - p. 313 38. Chapter 38 Axioms - p. 317 39. Chapter 39 Special Topics - p. 319 40. Chapter 40 Critical Thinking and Risk Management - p. 325 41. Chapter 41 Advice and Wisdom - p. 329 42. Appendix A Glossary - p. 333 43. Appendix B Templates - p. 339 44. Appendix C Example Device – Vivio - p. 375 45. Appendix D Useful References - p. 507 46. References - p. 509 47. Index - p. 511
