Preparing for the 2026 Deadline
CTI Consulting got its start in the fourth quarter of 2025, with its first assignment to perform a QMSR-focused internal audit assignment I wanted to take this opportunity to provide the insights I had as I performed this audit, so other medical device establishments are able to learn from my observations so they can be ready for the QMSR effective date of February 2, 2026.
For an establishment that is already certified to ISO 13485, compliance to the QMSR appears to be simple.
After all, the FDA has adopted the ISO 13485 standard as its framework, so there is no longer a need to ensure that each policy and procedure meets both ISO 13485 and 21 CFR 820 requirements, right?
Wrong. The QMSR, while it has adopted ISO 13485 for the basic quality management system requirements, now takes its focus away from the basic QMS, and now brings all the other ancillary standards, 21 CFR 803, 806, 821, and 830 into even greater focus. While there is an understanding that there shall be a QMS at all FDA-registered device establishment sites, and this will largely still be audited using the QSIT (Quality Systems Inspectional Technique) method, the other regulations, focusing on recalls, reporting, traceability, and device UDI labeling come to the fore, since the new QMSR states, by reference, that ISO 13485 AND these other standards are the expectation for device establishments worldwide.
As I put together my QMSR-centric audit checklist this time, I no longer used QSIT as my guide, looking at Management, Production & Process Controls, Design Control, CAPA, Change Control, Document/Records, Material Controls and Facility/Equipment Controls. Instead, the checklist started to look like a deep dive of the top half of the QSIT diagram: Medical Device Reporting, Reports of Corrections & Removals, and Medical Device Tracking, as well as a review of regulatory submission information associated with the medical device firm.
In other words, the QMSR takes a back-to-basics approach. The revised regulation accounts for the fact that if a company is ISO-registered, it has, more or less, a functional Quality Management System.
The FDA is now asking establishments to ensure that their regulatory paperwork and procedures are well-organized, well-supported, and readily available for review. Also, it is important to ensure that your firm’s electronic portals for FDA communications are readily available for use.
As your medical device firm prepares for 2026, the best thing you can do is to verify the integrity of basic regulatory establishment essentials, and if you aren’t registered to ISO 13485, now would be an excellent time to seek a registrar, since the QMS requirements will be redundant.
As we boldly approach 2026, many firms are making plans for their compliance improvements.
If any of the above discussion points strike a chord with you and you need assistance to get on track, please remember that CTI is here to help!
We are committed to our clients’ needs and want to lead you to success in 2026 and beyond!