TY - BOOK ID - 101099081 TI - Safety risk management for medical devices PY - 2022 SN - 0323918239 9780323918237 9780323857550 0323857558 9780323857550 PB - London, England : Academic Press, DB - UniCat KW - Health risk assessment. KW - Medicine, Preventive KW - Public health KW - Risk assessment KW - Environmental health KW - Assessment, Health risk KW - Health hazard appraisal KW - Health hazard assessment KW - Health risk appraisal KW - HRA (Public health) KW - Human risk assessment KW - Risk Assessment KW - Biomedical Technology KW - Risk Management KW - Health Risk Assessment KW - Risks and Benefits KW - Assessment, Risk KW - Benefit-Risk Assessment KW - Risk Analysis KW - Risk-Benefit Assessment KW - Analysis, Risk KW - Assessment, Benefit-Risk KW - Assessment, Health Risk KW - Assessment, Risk-Benefit KW - Benefit Risk Assessment KW - Benefit-Risk Assessments KW - Benefits and Risks KW - Health Risk Assessments KW - Risk Analyses KW - Risk Assessment, Health KW - Risk Assessments KW - Risk Benefit Assessment KW - Risk-Benefit Assessments KW - legislation & jurisprudence KW - organization & administration KW - Medical instruments and apparatus industry KW - Equipment Safety KW - Risk management. UR - https://www.unicat.be/uniCat?func=search&query=sysid:101099081 AB - Safety Risk Management for Medical Devices, Second Edition teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. Focusing exclusively on 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 practices, addressing safety risk management of medical devices, thus making it useful for those 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. Graduate-level engineering students with an interest in medical devices will also benefit from this book. 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 commercializing medical devices in line with the most current international standards and regulations. ER -