Quality & Certifications
Meeting and exceeding international standards for medical device manufacturing
ISO 13485:2016
Medical Devices Quality Management System
CE Marked
European Conformity Certification
FDA Registered
U.S. Food and Drug Administration
GMP Certified
Good Manufacturing Practice
Our Quality Commitment
Ensuring safety and excellence
100% material traceability
In-house testing laboratory
Clean room manufacturing
Strict quality control protocols
Post-market surveillance
Continuous improvement programs
ISO Certified
FDA Registered
CE Marked
GMP Compliant