Safety Risk Management for Medical Devices

Bijan Elahi

• Publisher: Academic Press
• Year: 2021
• eBook ISBN: 9780323918237
• Edition: 2
• Topic: Technology & Engineering
• Subtopic: Biomedical Science
• Index: Technology & Engineering

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. - Includes new coverage of ISO 14971:2019, ISO/TR 24971 - Presents the latest information on the history of risk management, lifetime of a medical device, risk management review, production and post production activities, post market risk management - Provides practical, easy-to-understand and state-of the-art methodologies that meet the requirements of international regulation

Table of contents

• Safety Risk Management for Medical Devices
• Chapter 1 Introduction
• Chapter 2 What Is a Medical Device?
• Chapter 3 Why Do Risk-Management?
• Chapter 4 The Basics
• Chapter 5 Understanding Risk
• Chapter 6 Risk Management Standards
• Chapter 7 Requirements of the Risk Management Process
• Chapter 8 Quality Management System
• Chapter 9 Usability Engineering and Risk Analysis
• Chapter 10 Biocompatibility and Risk Management
• Chapter 11 Influence of Security on Safety
• Chapter 12 The BXM Method
• Chapter 13 Risk Management Process
• Chapter 14 Risk Analysis Techniques
• Chapter 15 Software Risk Management
• Chapter 16 Integration of Risk Analysis
• Chapter 17 Risk Estimation
• Chapter 18 Risk Controls
• Chapter 19 Verification of Risk Controls
• Chapter 20 On Testing
• Chapter 21 Risk Evaluation
• Chapter 22 Risk Assessment and Control Table
• Chapter 23 Benefit-Risk Analysis
• Chapter 24 Risk Management Review
• Chapter 25 Production and Post-Production Activities
• Chapter 26 Traceability
• Chapter 27 Lifetime of a Medical Device
• Chapter 28 Safety Versus Reliability
• Chapter 29 Risk Management for System of Systems
• Chapter 30 Risk Management for Clinical Investigations
• Chapter 31 Risk Management for Legacy Devices
• Chapter 32 Risk Management for Combination Medical Devices
• Chapter 33 Basic Safety and Essential Performance
• Chapter 34 Relationship between ISO 14971 and other Standards
• Chapter 35 Risk Management Process Metrics
• Chapter 36 Risk Management and Product Development Process
• Chapter 37 Risk Management for Suppliers
• Chapter 38 Axioms
• Chapter 39 Special Topics
• Chapter 40 Critical Thinking and Risk Management
• Chapter 41 Advice and Wisdom
• Appendix A Glossary
• Appendix B Templates
• Appendix C Example Device – Vivio
• Appendix D Useful References
• References
• Index