Category Standard Organisation International Organization for Standardization (ISO) Type Standard Version 2016 Status Active This standard provides an overview of ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes 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 — Quality management systems — Requirements for regulatory purposes By accessing this content, you are leaving this website. The Agency takes no responsibility for the accuracy of content on the destination page.