All markets
Starter Document Review
Best for: Teams who want to test working with us on a small, defined piece of work.
You receive
- Findings report with suggested wording
- 30-min debrief call
Türkiye
Built in Türkiye, ready for every export market.
Türkiye’s medical device rules are aligned with the EU MDR. MDR compliance and export readiness for EU, US and Gulf markets for manufacturers based in Türkiye.
Regulatory framework
Türkiye’s Medical Device Regulation, published in 2021 and enforced by the Turkish Medicines and Medical Devices Agency (TİTCK), is aligned with the EU MDR. For manufacturers in Türkiye this is an advantage: a well-built ISO 13485 system and MDR-grade technical documentation serve the domestic market and form the base for export to the EU, the US and the Gulf.
Dates and requirements are summarized from the official sources linked on this page. Always check the current official text.
Recommended services
ISO 13485 Quality Management System
One QMS built to serve EU MDR, FDA QMSR, Türkiye and Gulf requirements: set-up, upgrade and training.
DetailsEU MDR & CE Marking
MDR transition, technical documentation, GSPR, ISO 14971 risk management and notified body preparation.
DetailsRemote Internal Audits
Independent ISO 13485, QMSR and MDR internal audits with reports written to withstand an FDA or notified body read.
DetailsValidation
Sterilization validation, test method validation, cleanroom and process validation reviews.
DetailsCAPA & Quality Processes
CAPA, nonconformance, complaints, document control, batch record review and product release.
DetailsPackages for this market
See all packages European UnionTürkiye
MDR Transition Support
Best for: Manufacturers selling in the EU who need to complete MDR certification.
You receive
- Transition plan
- GSPR checklist
- Technical file structure
- Pre-submission review
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
FAQ
Do you work on site in Türkiye?
Yes. We work remotely by default and visit sites in Türkiye for audits, validation reviews and training when it adds value.
We sell in Türkiye only. Why think about export now?
Because the same QMS and technical file can open the EU, US and Gulf markets later. Building them to the higher standard once is cheaper than rebuilding.
Can you support the responsible manager role?
We understand the Türkiye responsible manager requirements and can support the person in that role with procedures and training. The role itself is held by your own qualified staff.
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.