Description

Safety Risk Management for Medical Devices teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. It also removes the uncertainties associated with the understanding and application of related international standards. Focusing exclusively on the 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. This book comprehensively addresses safety risk management of medical devices, 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 commercialising medical devices in line with the most current international standards and regulations. The new edition also offers guidance on navigating the changes in the EU medical approval process. Readers using the new edition will find new chapters on risk management for suppliers, residual risk and risk management review. This second edition features 6 new chapters, 52 new sections, and 63 updated chapters/sections.