Risk Management in Medical Devices: An application of ISO 14971

This paper introduces ISO 14971 (Medical devices – Application of risk management to medical devices)'s role in medical device risk management, highlighting its integration with standards like ISO 13485 (Medical devices – Quality management systems – Requirements for regulatory purposes) and IEC 60601-1 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance) 123 . It focuses on the complete risk management process, from analysis to post-production, and underscores its importance in ensuring medical device safety.