Company Overview
The Bio-Medical Device Global Expansion Support Center is a comprehensive platform established to support Korean bio-medical device companies throughout the entire product lifecycle?from initial design and development to international regulatory approval?for successful entry into global markets.
The Center adopts a Zero-Trust verification framework, based on the principle of “Never trust, always verify.” This strategy goes beyond conventional cybersecurity, applying repeated, real-use scenario-based verifications from the design stage to proactively eliminate usability errors and safety risks, thereby strengthening in-house development capabilities.
To address key global regulatory requirements such as those of the U.S. FDA and EU MDR, the Center is equipped with specialized infrastructure and services including usability testing, cybersecurity and durability evaluation, clinical and preclinical validation, technical documentation support, and tailored training programs.
Furthermore, it operates a “Two-in-One” global collaboration system that links domestic and international regulatory institutions to minimize delays or rejections and streamline global market entry.
Located in Naepo New City, Hongseong County, Chungcheongnam-do, the Center serves as a strategic hub dedicated to resolving export bottlenecks and enhancing the global competitiveness of Korea’s bio-health industry through advanced, real-use-based infrastructure and international partnerships.
The Center adopts a Zero-Trust verification framework, based on the principle of “Never trust, always verify.” This strategy goes beyond conventional cybersecurity, applying repeated, real-use scenario-based verifications from the design stage to proactively eliminate usability errors and safety risks, thereby strengthening in-house development capabilities.
To address key global regulatory requirements such as those of the U.S. FDA and EU MDR, the Center is equipped with specialized infrastructure and services including usability testing, cybersecurity and durability evaluation, clinical and preclinical validation, technical documentation support, and tailored training programs.
Furthermore, it operates a “Two-in-One” global collaboration system that links domestic and international regulatory institutions to minimize delays or rejections and streamline global market entry.
Located in Naepo New City, Hongseong County, Chungcheongnam-do, the Center serves as a strategic hub dedicated to resolving export bottlenecks and enhancing the global competitiveness of Korea’s bio-health industry through advanced, real-use-based infrastructure and international partnerships.
