Global Certifications & Systemic Management Architecture

A fully-certified, medical-grade manufacturer backed by ISO 13485, MDSAP, FDA, and BSCI—guaranteeing 100% regulatory compliance and frictionless global market entry for your brand.

1.Core Quality & Safety Framework 

• ISO 9001: Quality Management System (QMS)

• ISO 14001: Environmental Management System (EMS)

• ISO 45001: Occupational Health & Safety Management System (OHSMS)

2. Medical-Grade Manufacturing Standards 

• ISO 13485: Medical Devices Quality Management System

• MDSAP (Medical Device Single Audit Program) Certification

• Japan Medical Device Manufacturer Registration (PMDA Compliance)

3. International Market Access & Social Responsibility

• US FDA Registered & Compliant

• Amfori BSCI (Business Social Compliance Initiative) Certified