Quality
In the field of medical devices and consumables, quality control is of paramount importance. All our products are designed and manufactured using quality-controlled metrics. These standards are incorporated at every stage of the manufacturing process: scientists and technicians use them in their laboratories and quality engineers measure them in inspections.
We have been awarded the ISO 9001:2008 and 13485:2003 certificates as well as the European Council Directive 93/42/EEC. All our products bear the CE mark and our manufacturing processes follow FDA Quality Systems Regulations.
All products continually undergo rigorous testing, analysis and quality trials to ensure their efficacy as well as their safety.
Our products undergo stringent testing in our quality control laboratories which employ protocol procedures that measure the integrity of each product.
Quality Control Procedures
- Highly equipped Analytical, Phsyical and Microbiological laboratories are used for raw material, processes and final product monitoring, testing and control.
- Environmental control and hygiene monitoring of production areas particularly clean rooms.
- Monitoring Bio-burden of raw materials as well as finished parenteral sterile products.
- Sterilization process monitoring and in-house validation studies according to the latest standard ISO 11135-1:2007.
- ETO Gas residual dissemination in accordance to ISO 10993-7:2009.
- Full documentation of all activities to facilitate backward traceability.
- Implementation of statistical sampling according to international standards.
- Calibration and validation of testing equipment and instruments to ensure accuracy of control.
