Safety Risk Management for Medical Devices

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