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Compliance & Quality

Standards That
Define Excellence

Our brand partners hold the highest international certifications in medical device manufacturing. Every product we distribute is backed by rigorous regulatory approval and quality management standards.

CE Marking
European Union · MDR 2017/745

All Tyromotion, Arthrex and Vermeiren products carry CE marking, confirming conformity with European Medical Device Regulation standards for safety and performance.

ISO 13485
International Medical Device QMS

ISO 13485 certification demonstrates our partners' commitment to a quality management system specifically designed for the design and manufacture of medical devices.

CDSCO
Central Drugs Standard Control Organization

Products distributed in India carry CDSCO registration — the mandatory Indian regulatory approval for medical devices issued by the Central Drugs Standard Control Organization.

FDA 510(k) / PMA
U.S. Food & Drug Administration

Key Arthrex and Tyromotion products hold FDA clearance, reflecting the highest standard of clinical evidence and device safety required by the United States regulator.

GMP Compliance
Good Manufacturing Practice

Manufacturing operations for all partner products follow Good Manufacturing Practice guidelines, ensuring consistent quality, safety and traceability throughout production.

ISO 9001
Quality Management Systems

ISO 9001 certification across our key brand partners affirms a robust, process-driven quality management culture — from design and procurement to distribution and customer service.

Our Commitment to
Regulatory Compliance

Every product we distribute is tracked, traced and compliant with applicable Indian and international regulations.

All products carry mandatory CDSCO / MDR 2017 registration for Indian market entry
Cold chain and storage protocols maintained for biological and temperature-sensitive products
Full post-market surveillance support provided to hospitals and healthcare institutions
Device traceability records maintained per Indian MDR 2017 requirements
Adverse event reporting and recall coordination in line with CDSCO guidelines
Regular team training on compliance and product safety updates from manufacturers

Questions About
Compliance?

Our team can provide regulatory documentation, CE certificates and CDSCO registration details for all distributed products.

Contact Our Team