In February 2022, FDA proposed a new Quality Management System Regulation (QMSR) to better harmonize with ISO

This is the third post in the series “The Practical Guide to the ISO 13485:2016 Practical Guide.” (See the first

This is the second post in the series “The Practical Guide to the ISO 13485:2016 Practical Guide.” If you missed the

Manufacturers everywhere waited a year and a half for additional guidance on the requirements of ISO 13485:2016, hoping