Map the path. See the risks.
Pathway strategy, technical-document gap analysis, quality-system gap analysis, market-access feasibility—built on our regulatory database. You see the route, the milestones, and the named risks before you commit.
Make medtech Lean-able.
Engineered regulatory systems that compress time-to-market — in every market you enter.
ISO 13485:2016
IEC 62304
ISO 14971:2019
IEC 62366-1
ISO 14155:2020
ISO 10993
IEC 60601
ISO/IEC 27001:2022
MDSAP
UDI / UDI-DI
EU MDR 2017/745
IVDR 2017/746
CE Marking
FDA 21 CFR Part 820
ISO 13485:2016
IEC 62304
ISO 14971:2019
IEC 62366-1
ISO 14155:2020
ISO 10993
IEC 60601
ISO/IEC 27001:2022
MDSAP
UDI / UDI-DI
EU MDR 2017/745
IVDR 2017/746
CE Marking
FDA 21 CFR Part 820
MFDS (식약처)
KGMP
K-IVDR
Korea SaMD Guidelines
HIRA Reimbursement
EU AI Act
Independent KLH
Pathway Strategy
Technical File Gap
Mock KGMP Audit
License Transfer DD
HIRA Reimbursement
MFDS Vigilance
Cybersecurity Submission
MFDS (식약처)
KGMP
K-IVDR
Korea SaMD Guidelines
HIRA Reimbursement
EU AI Act
Independent KLH
Pathway Strategy
Technical File Gap
Mock KGMP Audit
License Transfer DD
HIRA Reimbursement
MFDS Vigilance
Cybersecurity Submission
510(k)
De Novo
PMA
IDE
CER
DHF
DMR
STED
CAPA
Design Controls
Risk Management
Post-Market Surveillance
Software Validation
Sterilization Validation
SaMD
AI/ML SaMD
Real-World Evidence
Predicate Device
ISO 15223-1
ISO 11607
License Renewal
Promotional Review
Regulatory Intelligence
Usability Engineering
510(k)
De Novo
PMA
IDE
CER
DHF
DMR
STED
CAPA
Design Controls
Risk Management
Post-Market Surveillance
Software Validation
Sterilization Validation
SaMD
AI/ML SaMD
Real-World Evidence
Predicate Device
ISO 15223-1
ISO 11607
License Renewal
Promotional Review
Regulatory Intelligence
Usability Engineering
Where to start
Markets we serve
Country-specific regulatory programs. We run Korea directly and deliver across APAC through partners.
Explore marketsLifecycle services
Strategy, pathway, submission, approval, and operate. Hire us for one step or all of them.
Browse all servicesPlatforms
eQMS and RIM SaaS. The same systems our own team runs — usable in any market you sell into.
Browse all productsHow we work with you
We do the work, in the right order.
Documentation, submission, testing, cybersecurity, usability, quality-system build, reimbursement, license transfer — sequenced by workflows we have run before, with software handling the repetitive parts.
Sustain after market entry.
License-holder operations, vigilance, change notifications, advertising review, regulatory intelligence—your ongoing presence in the market.
Run it yourself, on our software.
eQMS, PLM, MES, and RIM SaaS—market-agnostic platforms your team operates directly. The same engineered workflows we run on your behalf, delivered as software.
Why teams choose Leanabl
Less rework
We put the regulatory work in the right order before the project starts, so your team spends less time redoing things that were avoidable.
Asked once, not twice
Inputs from your team enter the workflow once. We track project memory so your engineers are not asked for the same context again.
One contract, one team, one bill
No vendor stitching. No surprise scope. The person briefing you is the person delivering.
Korea, run directly
MFDS pathway, KGMP, and license holding are handled by our own team in Seoul—not subcontracted to a distributor.
Recent work
Still have a question about your device?
Tell us the device class and the market you are entering. We will come back with the pathway, the sequence, and the named risks.