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 the difficult questions, such as how to define risk acceptance criteria and 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 ...
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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 the difficult questions, such as how to define risk acceptance criteria and 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. Opening chapters introduce the concept of risk, the legal basis for risk management, and the requirements for a compliant risk-management process. The next group of chapters discusses the connection between risk management and quality systems, usability engineering and biocompatibility. This book delves into the techniques of risk management, such as fault tree analysis and failure modes and effects analysis, and continues with risk estimation, risk control, and risk evaluation. Special topics such as software risk management, clinical investigations, and security are also discussed. The latter chapters address benefit-risk analysis, and production and postproduction monitoring. This book concludes with advice and wisdom for sensible, efficient, and successful safety risk management of medical devices.
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Add this copy of Safety Risk Management for Medical Devices, 2nd Edition to cart. $125.97, new condition, Sold by Basi6 International rated 5.0 out of 5 stars, ships from Irving, TX, UNITED STATES, published 2022 by Academic Press.
Add this copy of Safety Risk Management for Medical Devices to cart. $134.29, like new condition, Sold by GreatBookPrices rated 4.0 out of 5 stars, ships from Columbia, MD, UNITED STATES, published 2022 by Academic Press.
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Fine. Trade paperback (US). Glued binding. 534 p. In Stock. 100% Money Back Guarantee. Brand New, Perfect Condition, allow 4-14 business days for standard shipping. To Alaska, Hawaii, U.S. protectorate, P.O. box, and APO/FPO addresses allow 4-28 business days for Standard shipping. No expedited shipping. All orders placed with expedited shipping will be cancelled. Over 3, 000, 000 happy customers.
Add this copy of Safety Risk Management for Medical Devices to cart. $135.65, new condition, Sold by GreatBookPrices rated 4.0 out of 5 stars, ships from Columbia, MD, UNITED STATES, published 2022 by Academic Press.
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Seller's Description:
New. Trade paperback (US). Glued binding. 534 p. In Stock. 100% Money Back Guarantee. Brand New, Perfect Condition, allow 4-14 business days for standard shipping. To Alaska, Hawaii, U.S. protectorate, P.O. box, and APO/FPO addresses allow 4-28 business days for Standard shipping. No expedited shipping. All orders placed with expedited shipping will be cancelled. Over 3, 000, 000 happy customers.
Add this copy of Safety Risk Management for Medical Devices to cart. $135.66, new condition, Sold by Paperbackshop rated 4.0 out of 5 stars, ships from Bensenville, IL, UNITED STATES, published 2021 by Elsevier Science.
