Browse our integrated solutions by market, lifecycle, or process.
Fast-track Class I device registration
Standard Class II–III MFDS registration
Registration + KGMP + HIRA in one program
MFDS approval for software and AI devices
Independent Korea License Holder
Annual compliance retainer
Full ongoing compliance management
Build your QMS from zero for KGMP
Pass the MFDS factory inspection
HIRA listing and NHI coverage
Prepare for an MFDS inspection
License transfer and regulatory due diligence
Pre-submission MFDS readiness check
