Safety Risk Management for Medical Devices / Bijan Elahi.
"Safety Risk Management for Medical Devices demystifies risk management, providing clarity of thought and confidence to the practitioners of risk management as they do their work. Written with practicing engineers, safety management professionals, and students in mind, this book will help reade...
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| Online Access: |
Full Text (via ScienceDirect) |
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| Format: | eBook |
| Language: | English |
| Published: |
London, United Kingdom :
Academic Press, an imprint of Elsevier,
[2018]
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| Subjects: |
Table of Contents:
- Front Cover; Safety Risk Management for Medical Devices; Copyright Page; Dedication; Contents; List of Figures; List of Tables; Biography; Preface; 1 Introduction; 2 Why Do Risk Management?; 2.1 Legal and Regulatory Requirements; 2.1.1 United States; 2.1.2 European Union; 2.1.3 MDD/AIMDD and transition to EU MDR; 2.2 Business Reasons; 2.2.1 Cost efficiency; 2.2.2 Avoiding recalls and field corrective actions; 2.2.3 Better communications; 2.3 Moral and Ethical Reasons; 3 The Basics; 3.1 Vocabulary of Risk Management; 3.1.1 Further elaborations; 3.1.1.1 Reasonably foreseeable misuse.
- 3.2 Hazard Theory3.3 System Types; 4 Understanding Risk; 4.1 Risk Definitions; 4.2 Types of Risk; 4.3 Contributors to Risk; 4.4 Risk Perception; 4.5 Risk Computation; 5 Risk Management Standards; 5.1 ISO 14971 History and Origins; 5.2 Harmonized Standards; 6 Requirements of the Risk Management Process; 6.1 Risk Management Process; 6.1.1 Risk analysis; 6.1.1.1 Hazard identification; 6.1.1.2 Risk estimation; 6.1.2 Risk evaluation; 6.1.3 Risk controls; 6.1.4 Risk control verification; 6.1.5 Monitoring; 7 Quality Management System; 8 Usability Engineering and Risk Analysis; 8.1 Key Terms.
- 8.2 Distinctions8.3 User-Device Interaction Model; 8.4 Use Failures; 8.5 Environmental Factors; 8.6 Design Means to Control Usability Risks; 8.7 Task Analysis; 8.8 Usability and Risk; 8.8.1 Data gathering; 8.8.2 Risk reduction and compliance with IEC 62366 process; 9 Biocompatibility and Risk Management; 10 The BXM Method; 10.1 System Decomposition; 10.2 Integration; 10.3 Quantitative Risk Estimation; 11 Risk Management Process; 11.1 Management Responsibilities; 11.2 Risk Management File; 11.3 Risk Management Plan; 11.3.1 Criteria for risk acceptability.
- 11.3.2 Other considerations for risk reduction end-point11.4 Hazard Identification; 11.5 Clinical Hazards List; 11.6 Harms Assessment List; 11.6.1 How to create a Harms Assessment List; 11.6.1.1 Method 1-Using published data; 11.6.1.2 Method 2-Using expert opinion; 12 Risk Analysis Techniques; 12.1 Fault Tree Analysis; 12.1.1 Introduction; 12.1.2 Theory; 12.1.2.1 Primary, secondary, and command Faults; 12.1.2.2 Immediate, necessary, and sufficient; 12.1.2.3 State of Component-State of System; 12.1.2.4 Common Cause Failures; 12.1.3 Symbols; 12.1.4 Methodology; 12.1.5 Ground rules.
- 12.1.5.1 Write faults as faults12.1.5.2 No gate-to-gate connections; 12.1.5.3 Mark low-likelihood faults as Basic Events; 12.1.5.4 Don't model passive components; 12.1.5.5 Be judicious in modeling secondary faults; 12.2 Mind Map Analysis; 12.2.1 Introduction; 12.2.2 Theory; 12.2.3 Methodology; 12.3 Preliminary Hazard Analysis; 12.3.1 Introduction; 12.3.2 Methodology; 12.3.2.1 Safety characteristics; 12.3.2.2 Identify System Hazards; 12.4 Failure Modes and Effects Analysis; 12.4.1 Facilitation of FMEAs; 12.4.2 Hierarchical multilevel FMEA; 12.4.3 Failure theory; 12.4.4 Ground rules.