MDREX, Medical Device, Digital Health Consulting Group
Expert Consulting for Medical Device Registration and Reimbursement in Korea.
Headquarters: Seoul, Republic of Korea
About MDREX, Medical Device, Digital Health Consulting Group
We are a boutique consulting firm in Korea specializing in providing strategic and operational consulting services to medical device and digital health companies (including DTx) for market access, focusing on Regulatory Affairs, Quality Management Systems, Reimbursement, and Clinical Consulting. Their team includes former professionals from the Korean Ministry of Food and Drug Safety (MFDS) and the Health Insurance Review and Assessment Service (HIRA).
Why Choose MDREX, Medical Device, Digital Health Consulting Group?
Team composed of former MFDS and HIRA professionals
Strong expertise in medical device, digital health, and DTx regulation in Korea
Comprehensive service covering RA, QA, Reimbursement, and Clinical needs
Services for both Korean market access and global expansion
Ability to act as Designated Marketing Authorization Holder (DMAH) in Japan
Specializations
7+ Services
Global Presence
2 Offices
Languages
3 Languages
Markets
5 Regions
Recent Updates
November 2025
October 2025