Expert

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.
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.
Sungyo Lee
  • Senior Advisor, MDREX;
  • Former Head of Medical Device Reimbursement Department at Health Insurance Review & Assessment Service (건강보험심사평가원);
  • Member at various special committees for reimbursement and benefits(MOHW and NHIS) at Korea Medical Devices Industry Association (한국의료기기산업협회);
  • Advisor at CLASS Law Firm
Minsoo 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.
HS Shin
  • Professional, medical device IDE(investigational Device Exemption), MDREX;
  • Over 20 years experience in establishing clinical trial plans for medical devices and pharmaceuticals;
  • Clinical trial lead at global pharma(Eli Lilly and Novo Nordisk) and medical device (Alcon and Abbott) companies.
Jennie H
  • Professional, Senior RA/QA/MA/BD, MDREX;
  • Over 20 years experience in obtaining licenses and permits for a wide range of medical devices from traditional to SaMD medical devices. Also experience with NHIS reimbursement qualification of medical acts and consumables.
Sujeong Yoo
  • Junior PRO, medical device RA/MA, MDREX

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.