Certifications & Compliance

Our quality management and products comply with major international pharmaceutical standards.

13485

ISO 13485

Medical device quality management system.

9001

ISO 9001

General quality management certification.

CE

CE Marking

Conformity for the European market.

GMP

GMP

Good Manufacturing Practice compliant.

DMF

US DMF

Drug Master File available on request.

14001

ISO 14001

Environmental management system.

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