Quality Policy

Quality Policy

We manufacture all our products in full compliance with international quality standards and apply a dedicated quality policy.

Our facility has ISO 13485:2016 & ISO 9001:2015 quality management systems (certified by RoyalCert®).

Our medical devices are being audited under the EU 93/42/EEC Medical Device Directive (certified by KIWA®).

The assembly, packaging, and sterilization processes of our sterile disposables are carried out inside the high-tech ISO 14644 compliant cleanroom area of our manufacturing plant. Precise final controls of our production are meticulously carried out by qualified staff inside special laboratory conditions.

Various tests are carried out to our sterile disposables by accredited laboratories, including but not limited to biocompatibility, particulate matter containment, filling volume, chemical, and physical tests.

Our electromechanical devices are;

• Compliant with ASHP and GMP guidelines and CE-certified under 2014/35/EU regulation.
• Tested and validated by the accredited laboratories in accordance with the following requirements:

     - IEC 60601 - Medical electrical equipment
     - IEC 61010 – Low Voltage Directive (LVD) safety for electrical equipment for measurement, control, and laboratory use
     - IEC 61326 - Electromagnetic Compatibility (EMC) for electrical equipment for measurement, control and laboratory use