Safety Risk Management for Medical Devices, Second Edition: A Comprehensive Guide

Author: Bijan Elahi

Publication Date: November 11, 2021

ISBN: 9780323857550, 9780323918237

Language: English

Publisher: Elsevier Science

Summary: Safety Risk Management for Medical Devices, Second Edition, is a comprehensive guide that teaches essential safety risk management methodologies for medical devices. It is compliant with the requirements of ISO 14971:2019 and focuses 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.

Target Audience: This book is 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.

Updates: 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. It includes new coverage of ISO 14971:2019, ISO/TR 24971, and presents the latest information on the history of risk management, lifetime of a medical device, risk management review, production and post-production activities, post-market risk management.

Key Features: This book provides practical, easy-to-understand, and state-of-the-art methodologies that meet the requirements of international regulation. It is a valuable resource for professionals and students in the MedTech sector, offering comprehensive insights into safety risk management for medical devices.

Why This Book Matters: Safety Risk Management for Medical Devices, Second Edition, is an essential guide for anyone involved in the development, manufacturing, or regulation of medical devices. It provides critical information on managing safety risks, ensuring compliance with international standards, and promoting the development of safe and effective medical devices. This book is a must-have for professionals and students seeking to advance their knowledge and skills in this field.