Category Standard Organisation International Organization for Standardization (ISO) Type Standard Version 2019 Status Active This standard provides an overview of ISO 14971:2019 Medical devices — Application of risk management to medical devices and defines key expectations to support safe and effective implementation. It is intended for implementers, vendors and health organisations seeking a clear, authoritative reference. Published by International Organization for Standardization (ISO), it may be used for procurement, assessment and governance contexts where alignment to recognised practice is required. Access Medical devices — Application of risk management to medical devices By accessing this content, you are leaving this website. The Agency takes no responsibility for the accuracy of content on the destination page.