United States
QMSR Gap Analysis
Best for: Manufacturers selling, or planning to sell, in the US.
You receive
- QMSR gap report
- Prioritized action plan
- Debrief with your team
United States (FDA)
The QMSR is live. Your internal audits now have a second reader.
The FDA QMSR has applied since February 2, 2026 and internal audit reports are now open to inspection. Internal audits, QMSR gap analysis and supplier audits for US-bound manufacturers.
Regulatory framework
In the United States, medical devices are regulated by the FDA under the Federal Food, Drug, and Cosmetic Act. The quality system requirements in 21 CFR Part 820 were replaced by the Quality Management System Regulation (QMSR), which incorporates ISO 13485:2016 by reference and took effect on February 2, 2026. Two consequences matter most in practice: an ISO 13485-based system is now the expected foundation, and internal audit, supplier audit and management review reports are no longer excluded from FDA inspection.
Dates and requirements are summarized from the official sources linked on this page. Always check the current official text.
Recommended services
Remote Internal Audits
Independent ISO 13485, QMSR and MDR internal audits with reports written to withstand an FDA or notified body read.
DetailsQMSR Gap Analysis
Check your ISO 13485 system against the FDA QMSR and related US requirements, with a prioritized action plan.
DetailsSupplier Audits in Türkiye & Europe
On-site supplier audits for US and EU manufacturers sourcing components or services from Türkiye and Europe.
DetailsISO 13485 Quality Management System
One QMS built to serve EU MDR, FDA QMSR, Türkiye and Gulf requirements: set-up, upgrade and training.
DetailsCAPA & Quality Processes
CAPA, nonconformance, complaints, document control, batch record review and product release.
DetailsPackages for this market
See all packages All markets
Remote Internal Audit
Best for: Manufacturers under ISO 13485, FDA QMSR or EU MDR who need an independent auditor.
You receive
- FDA-presentable audit report
- Nonconformity log
- CAPA recommendations
All markets
Annual Audit Program
Best for: Manufacturers who want continuous compliance without a full-time auditor.
You receive
- Audit program
- Audit reports
- Quarterly status summary for management review
FAQ
Do you work with US companies?
Yes. Most of our US work is remote: internal audits, QMSR gap analyses and CAPA support. We also audit suppliers on site in Türkiye and Europe for US manufacturers.
Can you act as our US Agent?
No. A US Agent must be physically present in the United States. We do not offer this service.
Do you prepare 510(k), De Novo or PMA submissions?
No. Our focus is the quality system. If you need a premarket submission, we can coordinate with a specialized US regulatory partner and make sure your QMS evidence is ready.
How do you handle time zones?
Remote audit sessions are scheduled in overlapping hours, typically US East Coast mornings. Document review happens asynchronously between sessions.
Let’s map your route to market in 30 minutes
Tell us about your device, target markets and timeline. You’ll leave the call knowing which requirements apply, where your gaps likely are and what to do first.