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.
| File Size : | 1
file
, 3.1 MB |
| ISBN(s) : | 9789267107745 |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 221 |
| Published : | 01/22/2020 |
