Safety Risk Management for Medical Devices

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 Influence of Security on Safety 12 The BXM Method 13 Risk Management Process 14 Risk Analysis Techniques 15 Software Risk Management 16 Integration of Risk Analysis 17 Risk Estimation 18 Risk Controls 19 Verification of Risk Controls 20 On Testing 21 Risk Evaluation 22 Risk Assessment and Control Table (RACT) 23 Benefit-Risk Analysis 24 Risk Management Review 26 Traceability 27 Lifetime of a Medical Device 28 Safety versus Reliability 29 Risk Management for System of Systems 30 Risk Management for Clinical Investigations 31 Risk Management for Legacy Devices 32 Risk Management for Combination Medical Devices 33 Basic Safety and Essential Performance 34 Relationship between ISO 14971 and other Standards 35 Risk Management Process Metrics 36 Risk Management and Product Development Process 37 Risk Management for Suppliers 38 Axioms 39 Special Topics 40 Critical Thinking and Risk Management 41 Advice and Wisdom Appendix A - Glossary Appendix B - Templates Appendix C - Example Device - Vivio Appendix D - Useful References

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• Engenharia biomédica

?Accessory; Advice; Apparatus; Appliance; Automation; Axioms; BXM method; Basic Safety; Benefit; Benefit-risk analysis; Benefit-risk ratio; Biocompatibility; Biologic; Biological hazards; Biological testing; CAPA; CER; Cassandras; Clinical hazards list; Clinical investigations; Clinical study; Cognitive traps; Combination medical device; Complacency; Complaint handling; Completeness of risk controls; Computer automation; Concept testing; Confidence; Contributors to risk; Creating a safety culture; Criteria for risk acceptability; Critical thinking; Cybersecurity; DFMEA; Decomposition; Device lifetime; Direct harm; Distributed system; Drug; Effectiveness; Efficiency; Essential Performance; Essential design outputs; Ethical; Expected service life; Explainability; Exploits; Exposure; FMEA; FSCA; FTA; Failure Modes and Effects Analysis; Fault Tree Analysis; Fault condition; Field corrective action; Harmonized standards; Harms assessment list; Hazard; Hazard theory; Hierarchical multi-level FMEA; High-resolution risk estimation; Human factors; IEC 60601-1; IEC 62366; ISO 10993; ISO 10993-1; ISO 14155; ISO 14971; ISO 14971:2019; Implementation; Indirect harm; Information for safety; Integral system; Integration; Interaction; Jargon; Legacy device; Legacy software; Legal; Life cycle; MDR; MIR; Management responsibilities; Medical device; Mental models; Mind Map Analysis; Moral; Normative reference; P-Diagram; PFMEA; PMCF; PMSR; PSUR; Personal liability; Post-Market Surveillance; Post-Market risk management; Primary mode of action; Process metrics; Product development