Safety Risk Management for Medical Devices: A Comprehensive Guide

By Bijan Elahi, this book provides a detailed guide on safety risk management methodologies for medical devices, focusing on ISO 14971:2019 standards. It offers practical, easy-to-understand methodologies that meet international regulation requirements, making it an essential resource for professionals in the MedTech sector, 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, providing guidance on developing and commercializing medical devices in line with the most current international standards and regulations.

Key Features:

• New coverage of ISO 14971:2019 and ISO/TR 24971
• 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
• Practical, easy-to-understand, and state-of-the-art methodologies that meet the requirements of international regulation

This book is a must-have for those in the MedTech sector who are responsible for safety risk management or need to understand risk management. It provides comprehensive guidance on developing and commercializing medical devices in line with the most current international standards and regulations.