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 INDICE: 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
- ISBN: 978-0-323-85755-0
- Editorial: Academic Press
- Encuadernacion: Rústica
- Páginas: 534
- Fecha Publicación: 25/11/2021
- Nº Volúmenes: 1
- Idioma: Inglés