Compliance & Quality

Certifications & Compliance

Our quality management systems, regulatory approvals, and compliance frameworks give buyers confidence in every order — from a single instrument to a full facility supply.

ISO 13485:2016

Medical Device Quality Management System

Issuing Body: BSI Group
Cert. No.: MD 600123
Valid Until: March 2027
Scope: Design, manufacture, and distribution of surgical instruments and medical devices

ISO 9001:2015

Quality Management System

Issuing Body: Bureau Veritas
Cert. No.: QMS 402987
Valid Until: November 2026
Scope: Manufacturing and distribution of surgical and dental instruments

CE Mark

European Conformity — Class I Medical Devices

Issuing Body: EU Authorised Representative
Cert. No.: CE-EU-2024-0831
Valid Until: Ongoing with MDR compliance
Scope: Reusable surgical instruments supplied to EU/EEA markets under MDR 2017/745

FDA Registered

US FDA Establishment Registration

Issuing Body: U.S. Food & Drug Administration
Cert. No.: FEI: 3012456789
Valid Until: Annual renewal
Scope: Class I exempt surgical instruments for US market distribution

WHO GMP

Good Manufacturing Practice

Issuing Body: World Health Organization
Cert. No.: WHO-GMP-2024
Valid Until: December 2026
Scope: Manufacturing practices for medical device production

CDSCO

Central Drugs Standard Control Organisation

Issuing Body: Government of India
Cert. No.: CDSCO/MD/2023/4521
Valid Until: July 2026
Scope: Manufacture and export of medical devices to Indian market