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Founder

Stephen Jeong

Founder of Leanabl Inc. Medical device regulatory affairs specialist focused on Korea (MFDS) market entry for foreign manufacturers.

About

Stephen Jeong is the founder of Leanabl Inc., a medical device regulatory consulting firm headquartered in Seoul, South Korea. Leanabl helps foreign medical device manufacturers navigate the Korean MFDS (Ministry of Food and Drug Safety) market entry process — including product registration, KGMP certification, KLH (Korea License Holder) services, post-market vigilance, and HIRA reimbursement listing.

Leanabl is built on three operating principles: No wasted motion (every deliverable answers a regulatory question), The work, not the show (senior practitioners handle engagements directly), and Priced before you commit (transparent fixed-fee pricing where the path is known).

Under Stephen's leadership, Leanabl has structured a focused portfolio of regulatory services and product modules covering the full medical device lifecycle — from regulatory pathway strategy to commercial operations.

Areas of Expertise

→Medical Device Regulatory Affairs
→MFDS Registration
→KGMP Certification
→Korea License Holder (KLH)
→HIRA Reimbursement
→EU MDR Compliance
→FDA 510(k) Submissions
→ISO 13485 Quality Management
→Medical Device Cybersecurity
→AI/ML Medical Devices (SaMD)
→Post-Market Surveillance

Languages

English · Korean (native)

Work with Leanabl

Looking for regulatory guidance for Korean medical device market entry? Get in touch to discuss your project.

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