One quality system, every market
The US FDA QMSR, the EU MDR, Türkiye’s regulation and the Saudi SFDA all build on ISO 13485. We help you build that foundation once and meet each market’s additions on top.
Priority market
United States (FDA)
FDA · QMSR, 21 CFR Part 820
Explore Priority marketEuropean Union (MDR)
Regulation (EU) 2017/745 · notified bodies
Explore Priority marketTürkiye
TİTCK · Medical Device Regulation aligned with EU MDR
Explore Phase 2Gulf (SFDA & UAE)
Saudi FDA · Medical Device Marketing Authorization
Explore- 01
One foundation
A single ISO 13485 QMS, risk management file and document structure.
- 02
Market add-ons
QMSR additions for the US, MDR technical documentation for the EU and Türkiye, SFDA dossier for the Gulf.
- 03
One audit program
Internal audits that cover all applicable requirements in one cycle.
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.