Expert services for every stage of your regulatory journey.
Define Your Exact Route to the Korean Market
A simple translation of your CE MDR or FDA 510(k) ...
Close QMS gaps before your KGMP inspection
Korean Technical File authoring to MFDS license
Device security compliance
Expert orchestration of device testing from plan to approved report.
IEC 62366-1 usability programs from planning through summative testing.
Foreign manufacturer KGMP certification for Korean market access.
HIRA reimbursement listing execution for Korean hospital market access.
Proactive MFDS product license renewal to prevent market authorization gaps.
MFDS license transfers and regulatory due diligence for M&A and distributor transitions.
Independent MFDS license holding, separate from your distributor
PMS and adverse event crisis management subscription
MFDS pre-approval for medical device promotional materials
Monthly curated Korean regulatory monitoring newsletter in English
Always-on assessment and MFDS filing for every product change
