FDA’s Quality Management System Regulation (QMSR) will align 21 CFR 820 to ISO 13485. Use this checklist to prep your QMS ahead of the expected 2026 go-live.
1) Gap assess ISO 13485 vs. current QSR controls
- Map procedures (design control, purchasing, production, servicing) to ISO 13485 clauses.
- Confirm risk-based approaches in SOPs and records.
- Align document control, training, and record retention to ISO 13485 language.
2) Risk management integration
- Trace design inputs/outputs to ISO 14971 risk controls.
- Ensure risk files feed verification/validation, labeling, and CAPA.
- Show risk-based supplier control and change control decisions.
3) Software/CSV and SaMD
- Clarify software lifecycle approach (IEC 62304/820.30) and validation of QMS software.
- Ensure cybersecurity and data integrity are captured in design and production controls.
4) Supplier and purchasing controls
- Re-qualify critical suppliers with ISO 13485-aligned criteria.
- Refresh quality agreements and monitor performance indicators.
5) CAPA and post-market
- Risk-prioritized CAPA with effectiveness checks.
- Complaint handling/medical device reporting alignment and vigilance signaling.
- Management review inputs reflecting risk and post-market data.
How MedReg AI helps
- Run a QMSR gap check against ISO 13485 language to highlight weak SOPs/records.
- Trace risk controls to design, labeling, and supplier files to evidence integration.
- Produce an executive gap summary for leadership before FDA inspections.
Start by updating your gap list, then assign owners and timelines. To trial MedReg AI, see /pricing or reach us at /contact.
