Get your QMSR-MDSAP Gap Assessment today!
- The Insider
- Feb 2
- 2 min read
Updated: Feb 8
Today is the day! It's been two years in the making and FDA finally announced the completion of incorporating ISO 13485: 2016 Medical Device - Quality Management Systems - requirements for regulatory purposes. This rule became effective on February 2, 2026, and it is now titled Quality Management System Regulations (QMSR). Who is affected?
The QMSR is applicable to finished device manufacturers who intend to commercially distribute medical devices. Some specific Class I medical device manufacturers are also affected by this change. Organizations that are MDSAP certified will also be impacted by this change, as there will be updates to the MDSAP audit approach on February 6, 2026, this Friday. One particular change will impact Medical Device companies that have SaMD (software as a medical device) with AI features.
Next steps:
Currently, the eCFR has not updated these changes, but we have a copy of such changes in an FDA docket and we are happy to share this with you!
We have already completed a Gap Assessment on the current MDSAP Audit Approach P0002.09, with the one that is awaiting to be published, P0002.10, and you can get it for free!
We are happy to perform a Gap Assessment on your documentation and update your QMS documents today! There is no transition period for this change, so email us today and get us to perform an interim internal audit for you with this change before your next scheduled external audit!
Next steps:
Although the eCFR has not yet updated these changes, we have a copy available in an FDA docket and are pleased to share it with you!
We have completed a Gap Assessment comparing the current MDSAP Audit Approach P0002.09 with the forthcoming P0002.10, and it is available to you at no cost!
We offer to conduct a Gap Assessment on your documentation and update your QMS documents immediately. As there is no transition period for this change, email us today to arrange an interim internal audit before your next scheduled external audit!
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