Certifications and compliance
Quality management frameworks and conformity references behind every shipment we coordinate. Documentation is provided per quotation.
Standards we operate against
ISO 13485
International Organization for Standardization
Quality management systems for medical devices.
ISO 9001
International Organization for Standardization
Quality management systems - general requirements.
CE Marking
European Union
Conformity with EU health, safety, and environmental requirements for medical devices placed on the EEA market.
Turkish Trade Registry
Republic of Turkey
Registered trade entity for international trade and distribution.
Disclaimer: medical device regulatory status varies by jurisdiction. CE marking, ISO references, and country-specific approvals listed on this site are provided for general business communication. Final regulatory documentation accompanies each quotation and shipment.
Ready to discuss your procurement requirements?
Send us a short brief - target market, certifications required, estimated volumes - and our partnerships team will reply within one business day.