Would you like to be part of our team to provide feedback to FDA?

On February 23, 2022 the U.S. Food and Drug Administration (FDA) published the proposed ruling of changes to the current 21 CFR part 820 – Quality System Regulation (QSR) and upon finalization, will be referred to as the ‘Quality Management System Regulation (QMSR).’ This ruling, among other changes, incorporates a significant shift incorporating by reference, the Quality Management System requirements of ISO 13485:2016.

As a Medical Device Division, we would like to have our collective voices heard! We are looking for a small team of volunteers to assist with collecting comments that will be submitted to FDA. To be eligible for participating on this important team, you must be working in the medical device industry and have experience with ISO 13485:2016 compliance.

Please submit your resume to James Shore (james@qualityleansolutions.com) to be considered for participation on the team. We’re looking for a team of 7 – 10 participants. If you can coordinate reviews from others at your location, please indicate this. We anticipate 2 to 3 online meetings. The document itself isn’t all that long and so we don’t anticipate a major time commitment. Please reach out to James Shore BY THURSDAY March 31st if you want to participate!

If you’d like to just share your comments, we welcome that as well! Once the team is in place, we will be sending out another announcement and how to submit your information.

Teresa Cherry, Chair
ASQ Medical Device Division


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