What FDA QSR and ISO 13485 Harmonization Means for Medical Device Companies

The new QMSR explained

On Jan. 31, 2024, the U.S. Food and Drug Administration (FDA) released its final rule for the new Quality Management System Regulation (QMSR).

The new QMSR is the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s quality system regulation (QSR) with the international consensus standard for medical device quality management systems, ISO 13485:2016.

Cue the applause: The medical device industry has been buzzing about harmonization between the FDA’s QSR and ISO 13485 since 2018, and now it’s finally happening.

Well, almost. The effective date of enforcement for the QMSR is Feb. 2, 2026. So, there are still a couple of years until medtech companies will need to comply with the new regulation.

Still, this is a major step toward harmonization, and one that medical device professionals have been anticipating for a long time.

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If you want to know more about this...

This is great information. If you are in the Chicago area, I invite you to attend the Innovate for Excellence Summit where the QMSR and ISO13485 will be among the topics discussed.

I won't share the link here because I don't want it to seem like advertising (although it kind of is), but you can find more details on the ASQ Chicago Website. Or email me for more information.