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Safety Risk Management for Medical Devices by Bijan Elahi (2021, Trade Paperback)

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About this product

Product Identifiers

PublisherElsevier Science & Technology

ISBN-100323857558

ISBN-139780323857550

eBay Product ID (ePID)5050071825

Product Key Features

Number of Pages424 Pages

LanguageEnglish

Publication NameSafety Risk Management for Medical Devices

SubjectGeneral, Biomedical

Publication Year2021

TypeTextbook

AuthorBijan Elahi

Subject AreaTechnology & Engineering, Medical

FormatTrade Paperback

Dimensions

Item Length9.2 in

Item Width7.5 in

Additional Product Features

Edition Number2

Intended AudienceScholarly & Professional

Dewey Edition23

Dewey Decimal610.28

Table Of Content1 Introduction 2 What Is A Medical Device? 3 Why Do RiskManagement? 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 BenefitRisk 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

SynopsisSafety Risk Management for Medical Devices, 2nd edition has been updated and significantly enriched to serve as a resource, and a reference for the practitioners of risk management. Fundamentally, the book removes ambiguities associated with the understanding and application of risk management for medical devices and teaches the essentials for compliance with the international standard: ISO 14971:2019. The 2nd edition offers best practices for robust, practical, and efficient performance of risk management towards commercialising medical devices for global markets. The book provides detailed instructions for Failure Modes and Effects Analysis, and Fault Tree Analysis, including tips for successfully preforming these techniques. The 2nd edition elucidates Common conflations such as: safety vs. reliability, and safe-by-design vs. protective-measures. Other popular topics covered in the 2nd edition are: Cybersecurity and safety, software risk management, risk management for clinical investigations, and risk management for legacy medical devices. Readers of this edition will find several new chapters on topics such as risk management for suppliers, how to define the lifetime of a medical device, risk management for systems of systems, and risk management reviews. The second edition features 6 new chapters, 52 new sections, and updates to 63 chapters/sections. Also, a new Appendix is added providing useful references for risk management practitioners. Key Features New to this edition: coverage of ISO 14971:2019, ISO/TR 24971:2020, Practical, easy-to-understand, and the state-of-the-art methodologies to meet the requirements of international regulatory agencies, A worked-out example of Risk Management File showing the application of the BXM method to a fictitious product. The example has been reviewed by the FDA and BSI. Book jacket., 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.

LC Classification NumberR856.6