Scaling Innovation Without Borders.
Based in Seoul, connected to the world. We bridge the gap between local medical device development and global market entry through a high-velocity, lean expert network.
A Network Built for Agility
Traditional consulting is slowed down by bureaucracy. At leanabl, we utilize a 'Hub and Spoke' model to provide instant expertise wherever your business scales. By integrating our Seoul HQ with a curated network of over 150+ regulatory experts and auditors across 24 countries, we ensure your product meets the highest standards—anywhere on the map.
24+ Countries
Covered by local regulatory specialists.
150+ Consultants
Ready for on-demand technical support.
24/7 Synergy
Across time zones to keep your project moving.
Seoul HQ
Active Projects: 12
Local Partners: 5
North America
Active Projects: 8
Local Partners: 10
Europe
Active Projects: 15
Local Partners: 8
APAC
Active Projects: 20
Local Partners: 12
Asia-Pacific (APAC)
Focus on Korean MFDS (KGMP), China, Japan, India.
North America
FDA 510(k) and PMA pathways.
Europe
EU MDR and IVDR requirements.
Emerging Markets
Latin America and Middle East.
Digital-First Collaboration
In today’s world, 'presence' isn't just about physical offices—it’s about seamless connectivity.
Seoul
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London
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New York
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Stronger Together
