It describes a systematic risk management process and defines the evidence required. The international standard ISO 14971 ‘Application of risk management to medical devices’ is essential for the implementation of these requirements. Even though risk management is required by law through the European Regulation (EU) 2017/745 on medical devices (shortened as MDR), well executed risk management can also have a lot of benefits for your company.īy preventing Field Safety Corrective Actions (FSCA) of devices already placed on the market, it not only saves you costs and resources long term but also assures the wellbeing of your patients, users and the environment. Risk management is a fundamental part of a medical device’s development and throughout its entire lifecycle. What is risk management for medical devices and why is it important? In conclusion – what you need to know about risk management.Risk management process under ISO 14971.Medical device risk management requirements of the MDR.What is risk management for medical devices and why is it important?.It offers guidance on developing and commercializing medical devices in line with the most current international standards and regulations. The new edition has been fully updated to reflect the state-of-the-art in this fast changing field. Graduate-level engineering students with an interest in medical devices will also benefit from this book.

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. 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.

Medical device risk management template