Certification

Kooper Medical Technology operates under a Quality Management System compliant with ISO 13485:2016, the internationally recognized standard for medical device manufacturing. This certification demonstrates our commitment to controlled processes, risk management, product traceability, and continuous improvement.

The company holds a valid Manufacturing License issued by the Central Drugs Standard Control Organization (CDSCO), Government of India, for the manufacture of Class C and Class D medical devices in compliance with the Medical Devices Rules, 2017.

Kooper Medical Technology is registered under the Micro, Small and Medium Enterprises (MSME) scheme of the Government of India, recognizing our commitment to structured growth, innovation, and contribution to the domestic manufacturing ecosystem.