Medical Devices Quality Management System
Our manufacturing facility is certified according to ISO 13485:2016, the global gold standard for the medical device industry.
This standard covers not only final product inspection, but the entire product life cycle from raw material intake to shipment.
Risk Management: Potential risks throughout the product life cycle—from production to clinical use—are identified, analyzed, and minimized for each tube type.
Full Traceability: Each product can be traced retrospectively via its LOT number, including raw materials used, production time, and sterilization cycle.
Clean Room Standards: Production is carried out in ISO Class 8 clean rooms on fully automated, touch-free production lines.
Sterilization: Gamma sterilization processes are validated according to ISO 11137 standards, ensuring a Sterility Assurance Level (SAL) of 10-6.
European Union In Vitro Diagnostic Regulation
We are fully compliant with the stringent requirements of the European Union’s IVDR regulation.
Replacing the former IVDD directive, IVDR introduces significantly stricter criteria for product safety and performance evidence.
GSPR: Our blood collection tubes have successfully passed all chemical, physical, and biological safety tests required for the EU market.
Clinical Evidence: Product performance has been validated through independent laboratory studies and clinical data.
Biocompatibility (ISO 10993): The tube body, caps, and additives have been tested and approved for safe contact with human blood.
Technical Documentation & PMS: Products are continuously monitored after market release through a robust Post-Market Surveillance (PMS) system.
Unique Device Identification (UDI)
All our products are labeled in compliance with GS1 standards using the UDI
(Unique Device Identification) system to ensure full integration with digital healthcare systems.
Automation Compatibility: Our labels are fully compatible with pre-analytical barcode scanning and sorting systems used in hospital laboratories.
Transparent Information: Expiry date, sterilization method, fill volume, and LOT number are clearly and permanently printed using laser or thermal transfer technology.
