The implementation of the Medical Device Marketing Authorization Holder (MAH) system has introduced greater flexibility and innovation opportunities to the industry. Leveraging the MAH system, we provide the one-stop solutions—including R&D, manufacturing, registration, and post-market services—for innovative startups, research institutes, and international brands. Our services span high-value consumables, drug delivery systems, clinical diagnostic devices, and active medical equipment.
Concept design, prototyping, design verification & validation
Material selection, performance testing, algorithm validation
Ensure design outputs meet target market regulations
Compile technical documentation (e.g., risk analysis reports, software documentation, clinical evaluation reports)
We assist MAH clients with product classification, sample testing, clinical evaluation, and registration dossier preparation to help ensure market access in both domestic and international markets.
System Setup & Maintenance:
Build and maintain QMS compliance with ISO 13485 / GMP
Audit Readiness:
Prepare for regulatory authority and notified on-site inspections
Ongoing Compliance:
Adverse event monitoring, change control, annual self-inspections, risk assessments, safety updates
Lifecycle Managenment:
Assist in product upgrades, change notifications, and renewal registrations
