Quality & Certifications
Compliance international buyers can rely on
Our products and processes are aligned to the world's leading healthcare standards — with the documentation your market requires, prepared for you.
ISO
ISO 13485 / 9001
Quality management systems for the design and manufacture of medical devices.
CE
CE Marking
European conformity, enabling access across EU and EEA markets.
FDA
US FDA
Registered and listed device compliance for the United States market.
GMP
GMP
Good Manufacturing Practice certified production lines.
WHO
WHO-GMP
Production aligned with World Health Organization guidelines.
QC
Quality Inspection
Independent pre-shipment inspection on every export order.
PKG
Packaging Standards
Export-grade, regulation-compliant protective packaging.
COO
Certificate of Origin
Chamber-attested origin documentation for customs clearance.
Need certificates for a tender?
We prepare product-specific certification packs on request.
