Our Quality Policy
International standards at every stage of production.
Quality at Every Step
We manufacture at international standards with our quality policy based on continuous improvement and customer satisfaction.
Quality Certificates
ISO 9001:2015
Our ISO 9001:2015 certificate covering the general quality management system encompasses the principles of customer focus, leadership, process approach and continuous improvement.
Valid since 2008EN ISO 13485:2016
EN ISO 13485:2016, the quality management system standard specific to medical devices, includes risk management, verification and validation activities.
Valid since 2016CE Certificate
The CE certificate, active since 2002 under the European Union Medical Devices Directive, is the fundamental assurance for exporting to the EU market.
Valid since 2002Turkish Ministry of Health
With the production permits and compliance certificates issued by the Ministry of Health of the Republic of Turkey, the compliance of our products with domestic and international health legislation is ensured.
Valid since 1983TSE
With Turkish Standards Institution compliance certificates, the conformity of our products to Turkish Standards has been tested and verified.
Valid since 1990GMP – Good Manufacturing Practices
All our production processes are conducted in accordance with Good Manufacturing Practices (GMP) principles, from raw material acceptance to final product shipment.
Valid since 2010Production Quality Process
5-stage quality assurance from raw material to finished product.
Raw Material Control
Acceptance of test-approved cotton and chemical inputs.
Production
Gauze and bandage production under ISO conditions.
Quality Testing
Laboratory durability, elasticity and sterility tests.
Packaging
GMP-compliant sterile/non-sterile packaging.
Shipment
Perfect delivery with customer-approved lot tracking.
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Contact us for certificate copies and technical documents.
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