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Safety Risk Management for Medical Devices
Safety Risk Management for Medical Devices
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Excellent- More about Safety Risk Management for Medical Devices
The book "Safety Risk Management for Medical Devices, Second Edition" is a comprehensive guide that provides practical methodologies for assessing and managing safety risks in medical devices, compliant with ISO 14971:2019. It is useful for professionals in the MedTech sector, including design engineers, product engineers, and regulatory affairs, as well as graduate-level engineering students interested in medical devices.
\n Format: Paperback / softback
\n Length: 534 pages
\n Publication date: 25 November 2021
\n Publisher: Elsevier Science & Technology
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Safety Risk Management for Medical Devices, Second Edition is a comprehensive guide that provides essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. Focusing exclusively on the safety risk assessment practices required in the MedTech sector, this book offers practical and easily comprehensible approaches rooted in current industry best practices. It addresses the critical aspects of safety risk management for medical devices, making it valuable for individuals 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. Additionally, graduate-level engineering students with an interest in medical devices will also find this book to be an invaluable resource.
The new edition of this book has been thoroughly updated to reflect the latest advancements and developments in this fast-changing field. It provides guidance on developing and commercializing medical devices in alignment with the most current international standards and regulations.
In conclusion, Safety Risk Management for Medical Devices, Second Edition is a must-read for anyone involved in the design, development, and regulation of medical devices. It offers practical and effective methodologies for assessing and managing safety risks, ensuring the safety and effectiveness of medical devices in the marketplace.
\n Weight: 1108g\n
Dimension: 191 x 238 x 32 (mm)\n
ISBN-13: 9780323857550\n
Edition number: 2 ed\n
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