AAMI has adopted this companion handbook to ISO 13485:2016, Medical devices—Quality management systems—Requirements for regulatory purposes. It provides users with practical guidance and accurate interpretation of the requirements specified in the standard. This resource replaces ISO 14969.

AAMI/ISO 13485:2016, Medical devices—A practical guide, offers device manufacturers step-by-step guidance applicable to the all stages of a medical device's life cycle from gathering customer requirements to design and through to post-market surveillance of devices.

This go-to resource is ideal for regulatory, compliance, quality management professionals who are committed to implementing and maintaining a quality management system that is effective and meets applicable regulatory requirements.