QMSR Gap Analysis
The QMSR amends 21 CFR Part 820 to incorporate ISO 13485:2016 by reference. A certified ISO 13485 system is the right foundation, but it is not automatically QMSR-compliant: Part 820 keeps US-specific requirements, and other FDA regulations still apply alongside it. We map exactly where your system stands.
Clause-by-clause review
Your procedures and records checked against ISO 13485:2016 as incorporated by the QMSR, plus the Part 820 additions and definitions.
Connected FDA requirements
Interfaces with Medical Device Reporting (21 CFR 803), corrections and removals (Part 806) and UDI (Part 830) reviewed at the QMS level.
Inspection exposure check
Internal audit, supplier audit and management review records assessed as an FDA investigator would now read them.
Prioritized action plan
Findings ranked by risk and effort, with a realistic sequence your team can execute.
This is a quality system review. Premarket submissions (510(k), De Novo, PMA) and US Agent services are outside our scope; where needed we coordinate with specialized US partners.
FAQ
We are ISO 13485 certified. Do we still need a gap analysis?
Usually a short one. Certification shows conformity to the standard; the QMSR adds US-specific requirements and changes what FDA can review during an inspection. A focused gap analysis tells you whether those differences are already covered.
Do you work with US companies?
Yes. We work remotely with US manufacturers and with non-US manufacturers selling into the US. Typical engagements are internal audits, QMSR gap analyses and on-site audits of suppliers in Türkiye and Europe.
Other services
Remote Internal Audits
Independent ISO 13485, QMSR and MDR internal audits with reports written to withstand an FDA or notified body read.
ISO 13485 Quality Management System
One QMS built to serve EU MDR, FDA QMSR, Türkiye and Gulf requirements: set-up, upgrade and training.
EU MDR & CE Marking
MDR transition, technical documentation, GSPR, ISO 14971 risk management and notified body preparation.
Supplier Audits in Türkiye & Europe
On-site supplier audits for US and EU manufacturers sourcing components or services from Türkiye and Europe.
Validation
Sterilization validation, test method validation, cleanroom and process validation reviews.
CAPA & Quality Processes
CAPA, nonconformance, complaints, document control, batch record review and product release.
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.