Quality Assurance
Certified to
global standards.
Every instrument meets or exceeds international regulatory requirements.
Our Certifications
ISO 13485
International Organization for Standardization
Medical devices quality management system. Demonstrates consistent ability to provide medical devices and related services that meet customer and regulatory requirements.
Valid until 2026-12-31
CE Marking
European Commission
Conformité Européenne certification for medical devices sold in the European Economic Area. Products meet EU safety, health, and environmental protection standards.
FDA Registration
U.S. Food and Drug Administration
United States Food and Drug Administration facility registration. Enables legal distribution of medical devices in the US market.
WHO GMP
World Health Organization
Good Manufacturing Practice certification issued by the World Health Organization, ensuring consistent production and quality control standards.
Applicable Standards
Material Standards
- ASTM A276 — Stainless Steel Bars
- ASTM F899 — Surgical Instruments
- ISO 7153 — Instrument Materials
Manufacturing
- ISO 9001:2015 — Quality Management
- ISO 13485:2016 — Medical Devices
- EN ISO 10993 — Biocompatibility
Sterilization
- ISO 11135 — EO Sterilization
- ISO 17665 — Steam Sterilization
- AAMI ST79 — Autoclave Standards
Our Commitment
Quality is not an option.
It is our baseline.
Every instrument passes multi-stage quality control before leaving our facility.