QMSR and ISO 13485: Deciphering the Differences

QMSR and ISO 13485 - talk about a tale of two regulations. QMSR and QSR do sound practically the same, but that one

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