FDA's Quality Management System Regulation takes effect on 2 February 2026. Manufacturers that have not completed alignment work now have a quarter left. This checklist reflects what our quality consultants have seen succeed.
Documents
- Quality manual references ISO 13485:2016 clauses and the QMSR's FDA-specific requirements, with a terminology mapping (organisation/manufacturer, and similar).
- Procedures for complaint handling explicitly support Medical Device Reporting decisions.
- Record control procedure covers signature and date expectations and the medical device file / device master record relationship.
Evidence
- At least one internal audit against the QMSR completed, with findings closed or in CAPA.
- Management review minutes showing regulatory requirements as an input.
- Risk management applied to production and post-market processes, not only design.
People
- Internal auditors and QA reviewers trained on ISO 13485 structure and the QMSR differences.
- An inspection response plan updated for the replacement of QSIT.
If the list looks long, Vakula can supply a quality engineer or a small team for the final quarter. See GxP audit and quality.