KoBridge Co Ltd
Medical Device Consulting: Regulatory Affairs and Quality Assurance.
Headquarters: Seoul, Korea
About KoBridge Co Ltd
We are an international medical device consulting firm specializing in regulatory affairs and quality system compliance. Founded in South Korea in 2007, and later expanding to Switzerland in 2021, the company provides expertise for global market submissions, including the US (FDA), Europe (CE Marking/MDR), Canada (MDSAP), and particularly, South Korea (MFDS).
Why Choose KoBridge Co Ltd?
15+ years of experience helping medical device companies achieve global compliance
Dual presence in key regulatory hubs (Korea & Switzerland) for Eurasian access
Specialists in complex device types, including combination and animal-origin devices
Services cover the full lifecycle: regulatory strategy, QMS, clinical evaluation, and submission
Founder is a former regulatory expert and Notified Body auditor, offering unique insight
Specializations
8+ Services
Global Presence
2 Offices
Languages
3 Languages
Markets
9 Regions
Recent Updates
January 2022
October 2021
July 2021