Yangha Cho. PhD

  • Senior Advisor, MDREX;
  • Active in medical device research, policy, licenses/permits, and training for over 30 years. Advisor of medical device matters at MDREX;
  • Director and head of medical device division/orthopedic rehabilitation division, advanced analysis team and materials division, medical device standards division, medical device review division at MFDS. Career official at MFDS (Ministry of Food and Drugs Safety, 식품의약품안전처);
  • Former head of National Institute of Medical Device Safety and Information (한국의료기기안전정보원);
  • Graduate of Yonsei University and was a post-doctorate researcher at Korea Institute of Science and Technology. Also serves as a visiting professor in the field of medical device regulation policy at Dongguk University.
Uihyeong Byun

  • Senior Advisor, MDREX;
  • Former Director of Review Operation Department,  Review Management, Listing and Pricing at Health Insurance Review and Assessment Service (HIRA)
  • Former Committee member of nHTA, Developing Technology at National Evidence-based Healthcare Collaborating Agency(NECA) and listing and re-assessment at HIRA
Yongwoo Kim

  • Co-Founder (CEO), Senior RA/QA/MA/BD, MDREX;
  • Over 20 years experience in digital health and medical device licensing and NHIS reimbursement, as well as medical data collection, use and transfer (ex: Cloud SaaS as SaMD);
  • Served as an Expert on the above topics at Kim and Chang law firm for over 10 years;
  • MFDS (=Korea FDA) TF reviewer official and KGMP lead investigator. Conduct various review of SaMD/SiMD and other innovative medical devices/digital medical devices;
  • Lead auditor at TÜV-SÜD Korea for Europe, Japan, Canada (ISO13485/MDD/JGMP/CAMCAS Auditor). Also served as test engineer for digital/electronic medical devices (IEC 60601/IEC 61010);
  • Software engineer at Samsung and LG Electronics (WCDMA, Embedded System);
  • Yonsei University Electrical Engineering and Computer Science, BS/MS.
Wonwoo Lee

  • Vice President (COO), Senior RA/QA/MA/BD, MDREX;
  • Experienced Senior Manager with a proven track record in leading successful investment opportunities across diverse industries, including healthcare, medical devices, aviation and insurance companies.
  • Demonstrated expertise in strategic decision-making, financial analysis, and portfolio management within the private equity sector.
  • Skilled in building strong relationships with clients and stakeholders, with a particular focus on the medical device industry.
  • Advised global clients on RA/QA/MA/BD matters to establish their business in Korea as well as other compliance matters for the Korean market
  • Advised and coordinated with global pharmaceutical and medical device companies in managing product life-cycles including preparing preliminary injunctions, main actions, etc. to protect client's intellectual properties.
  • Peking University, Beijing, China (MBA 2018)
  • University of Law (Moorgate), London, UK (L.L.B 2011)
  • Boston College, MA, USA (B.S. Operations Management, 2004)
JaeHyun Park

  • Lead Director,  Japan and Japanese Medical Device Expert, MDREX;
  • Worked and studies in Japan, providing professional advises on regulations in medical device field;
  • Supporting domestic medical device manufacturer obtaining product approval from Japan PMDA, etc.
Sujeong Yoo

  • Professional, medical device RA/MA/QA/BD, MDREX
  • Product Approval​, KGMP Certification​, Reimbursement Assessment

  • In/Out-bound services​ for Korean clients​ (Europe/USA/Taiwan)​
Mijung Kim

  • Professional, medical device RA/MA/QA/BD, MDREX
  • Product Approval​, KGMP Certification​, Reimbursement Assessment
  • Approval Management​ (Europe/MFDS/APAC/Middle East/CIS/ Africa)​
Sangheon Lee

  • PRO, medical device RA/MA/QA/BD, MDREX
  • Product Approval​, KGMP Certification​, Reimbursement Assessment

Numerous field experts in addition to the experts introduced above are currently team members at MDREX. And with MOUs entered into with various specialty advisors, this allows MDREX to provide advice and guidance in the Korean market tailored to our clients’ exact needs.