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.
- Licensed Administrative Agent (General) – a national qualification
in South Korea
- Tel: +82-2-2054-3458 Email:
yangha.cho@mdrex.co.kr
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Euihyeong Byeon
- 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
- Tel: +82-2-2054-3458 Email:
joy1004@mdrex.co.kr
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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.
- Tel: +82-2-2054-3458 Email:
yongwoo.kim@mdrex.co.kr
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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)
- Tel: +82-2-2054-3471 Email:
wonwoo.lee@mdrex.co.kr
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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.
- Tel: +82-2-2054-3470 Email:
jhpark@mdrex.co.kr
|
Sujeong Yoo
Sojeong Park
- PRO, medical device RA/MA/QA/BD, MDREX
- Product Approval, KGMP Certification, Reimbursement Assessment
- Tel: +82-2-2054-3475 Email:
sj.park@mdrex.co.kr
|
Sangheon Lee
- PRO, medical device RA/MA/QA/BD, MDREX
- Product Approval, KGMP Certification, Reimbursement Assessment
- Tel: +82-2-2054-3443 Email:
sh.lee@mdrex.co.kr
|
Semin Kim
- PRO, medical device RA/MA/QA/BD, MDREX
- Product Approval, KGMP Certification, Reimbursement Assessment
- Tel: +82-2-2054-3476 Email:
sm.kim@mdrex.co.kr
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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.