Safety Risk Management for Medical Devices demystifies risk management, providing clarity of thought and confidence to the practitioners of risk management as they do their work. Written with practicing engineers, safety management professionals, and students in mind, this book will help readers tackle difficult questions, such as how to define risk acceptance criteria, or how to determine when to stop risk reduction.
This book delivers not only theory, but also practical guidance for applying the theory in daily risk management work. The reader is familiarized with the vocabulary of risk management and guided through a process to ensure compliance with the international standard ISO 14971 – a requirement for all medical devices. This book outlines sensible, easily comprehensible, and state-of-the-art methodologies that are rooted in current industry best practices.