• MDD 93/42 medical devices directive is our path to follow from procurement through sales.

• ISO 9001 and ISO13485 are the basis for our quality management system for medical devices.

• All relevant records of products are kept for 10 years.

• A risk analysis is conducted in design stage of the products conforming to ISO14971 Risk Analysis in Medical Devices Standards. Production starts after the analyzed prototype is approved by the customer.

• Production is made in a CLASS 10000 hepa filtered area, followed thermoform packaging where heat calibration and labeling is made according to EN 980 standards for graphic symbols of medical device labeling.

• Products to be sterilized are processed in our in-house EN 550 validated Ethylene Oxide sterilization unit. Upon customer demand, the products of Drape Group are sterilized by Gamma rays in a certified company that we cooperate on occasional requirements.

• In both processes all products are validated in terms of quality standards.

• Quality control procedures are applied to products after sterilization processes in quarantine rooms and upon successful results, products are stored in the controlled areas until the shipment to customer.

Theme of Production

Customer demand is where we set out in our production. Products that we customise with respect to customers specifications are shipped after various control procedures of medical directives, quality standards.