Safety Risk Management for Medical Devices (Elsevier Books)

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 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 practice. This book comprehensively addresses safety risk management from the standpoint of a wide variety of medical devices, making it useful for those in the MedTech sector who need to know about safety risk management (including design engineers, product engineers, development engineers, software engineers); Quality assurance and regulatory affairs staff in medical device companies; Graduate level biomedical engineering students with an interest in medical devices. 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 30 new chapters/sections, and 25 updated chapters/sections. New to this edition: coverage of ISO 14971:2019, ISO/TR 24971, Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD)New chapters on: history of risk management, lifetime of a medical device, risk management review, production and post production activities, post market risk managementProvides practical, easy-to-understand and state-of the-art methodologies that meet the requirements of international regulation