People first.Technology lean.
We help foreign manufacturers navigate MFDS registration, KGMP certification, and post-market obligations — with no wasted steps.
“Korea's MFDS requirements, KGMP factory inspections, and post-market obligations form a labyrinth — in a regulatory language most global RA teams don't speak fluently.”
Most foreign manufacturers enter Korea underprepared and pay for it in delays, deficiency notices, and failed audits. That's the problem we started Leanabl to solve.
People who know the system.
Software that keeps it precise.
At Leanabl, human judgment always comes first. Our technology exists to make that judgment faster, more accurate, and easier to act on.
A team built around Korea's regulatory requirements
Our regulatory specialists have deep experience in MFDS submissions, KGMP requirements, and post-market obligations. They've guided foreign manufacturers through every stage of Korea's approval process.
- MFDS Regulatory Pathway Strategy & Gap Analysis
- Technical Documentation (STED) & Submission Defense
- KGMP Factory Inspection Preparation & CAPA
- HIRA Reimbursement & License Transfer (KLH)
Compliance tools built by the same team that uses them
We built our software platforms because we needed them ourselves. They're designed around the actual work of regulatory compliance — not a generic workflow tool adapted for MedTech.
- EQMSDocument control, CAPA, risk, design & audit management
- PLMBOM, engineering change orders & requirements traceability
- MESWork orders, eDHR, equipment calibration & production records
- RIMGlobal registration tracking, UDI management & submission history
Every aspect of your Korea compliance, covered.
How a typical engagement unfolds.
We start with a clear picture
Regulatory Pathway Strategy, Technical Document Gap Analysis, KGMP Gap Analysis, and Reimbursement Feasibility — before you commit budget, you'll know exactly what's ahead.
Then we do the work
STED documentation, MFDS submission, testing management, cybersecurity and usability engineering, KGMP inspection preparation, HIRA reimbursement, license transfer — modular or turn-key.
And we stay with you after clearance
Premium KLH (독립 대리인), adverse event reporting, regulatory intelligence, advertising pre-approval, and change notification management — ongoing, as long as you're in the market.
A few examples of our work.
“MFDS SaMD approval in 4 months”
Structured documentation eliminated deficiency notices entirely. First submission cleared with no supplemental requests.
“KGMP certified on first inspection”
Gap closure, preparation, and on-site support delivered a clean certificate — no major non-conformities raised.
“License recovered from distributor”
Full regulatory due diligence and KLH transfer completed without interrupting commercial operations during the transition.
Let's figure out your Korea regulatory path together.
Start with a conversation. We'll tell you exactly what your device needs, how long it will take, and what it will cost — no vague estimates.
Schedule a Strategy Call