Bio-Medical Device Global Expansion Support Center

Bio-Medical Device Global Expansion Support Center

Global Expansion of Medical Devices: From Preparation to Local Connections

Our Bio-Medical Device Global Expansion Support Center provides a comprehensive support system for domestic medical device companies to enter the global market, offering assistance from overseas regulatory approval preparation to local evaluations and connections with specialized institutions.

Through a partnership with a European Notified Body (NB) specializing in AI and SaMD, and a collaborative network encompassing European Authorized Representatives (EU AR), overseas testing laboratories, and local usability evaluation centers, we support EU MDR and FDA compliance and facilitate connections with specialized agencies.

By providing tailored support that considers product characteristics, target countries, and certification stages, we minimize trial and error during the international regulatory approval process and help domestic medical device companies successfully enter the global market.

EU MDR & FDA Support | Overseas Usability Evaluation | Connection with Specialized European Institutions | Global Expansion Network

10F, Jukheon Information Center, 158 Gwanjeodong-ro, Seo-gu, Daejeon, Republic of Korea (35365)