ISO 13485:2016 is the standard for the development, implementation and maintenance of a QMS for medical device manufacturers and suppliers. Some of these key changes are:
- Risk-based approach to developing QMS.
- Documented files required for any software used for QMS as well as each manufactured device.
- Ongoing training required for specific skills defined for those involved in the QMS.
- Incorporation of risk into product realization and post-market feedback.
This standard was revised to provide an international standard that can be harmonized across multiple regions and regulatory requirements.
