The Quality Management System Regulation took effect on 2 February 2026, and FDA now inspects device manufacturers against ISO 13485:2016 as incorporated, plus the FDA-specific requirements. Our detailed note on the differences is here. This is a short update on what we have seen in the first weeks.
Inspection approach
Inspections are structured around the ISO clause order rather than the old QSIT subsystems. Manufacturers with ISO 13485 certification report that the experience is familiar; those without it have had to guide inspectors through their own structure, which takes time.
Common questions from inspectors
- Show how regulatory requirements are an input to management review.
- Show how complaint files support Medical Device Reporting decisions.
- Show risk management for production processes and suppliers, not only design.
Where help is still needed
Smaller manufacturers are the ones most often still closing gaps, particularly on supplier agreements and on record signature and date discipline. Vakula supplies quality engineers on short engagements to close those items. Contact us through the enquiry form.