Safety Risk Management for Medical Devices

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.