Why Choose Us
Certified Quality & Global Standards
Certified Quality Assurance
EU Compliance: CE MDR (NB 2797), UK Responsible Person
US Standards: FDA-registered facility (FEI 3015587162)
Indonesia : AKL
Global Certifications: ISO 13485:2016
Local Market Access: We guide partners through regional certification processes (e.g., Saudi SFDA, EUDAMED registration)