Full Description
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.
Contents
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
