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: +82-2-3400-0820 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: +82-2-3400-0823 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: +82-2-3400-0820 Email:
yongwoo.kim@mdrex.co.kr
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Wonwoo Lee. MBA
- 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
- Served as an Interpretation Officer (1LT) in the Republic of Korea Army
from 2005 to 2008. Key posts included the Blue House, TROKA, and UNCSB
JSA.
- 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)
- Served as an Interpretation Officer (1LT) in the Republic of Korea Army
from 2005 to 2008. Key posts included the Blue House, TROKA, and UNCSB
JSA.
- Tel: +82-2-3400-0822 Email:
wonwoo.lee@mdrex.co.kr
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Jaehyun Park
- Regional Head, CJO, 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: +82-2-3400-0821 Email:
jhpark@mdrex.co.kr
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Ilhwan Hwang. MBA
- Commercial Director, MDREX
- Commercial Director with unparalleled expertise in new business creation
and distribution development, driving innovation and growth in the
healthcare and medical device market.
- Accumulated nearly 20 years of experience at Johnson & Johnson
Medical Korea Ltd., holding a wide range of responsibilities in sales
and marketing across various business units including Ethicon Endo
Surgery, Cordis, Depuy Spine, and Depuy Synthes.
- Sogang University, International Business, MBA (2005)
- Hanyang University, English Language and Literature, BA (1995)
- Tel: +82-2-3400-0833
Email:ilhwan.hwang@mdrex.co.kr
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Jungmin Park. PhD
- Senior Expert, Senior RA/QA/MA/BD, MDREX
- A seasoned professional with comprehensive experience and strategic
insight in the field of medical devices and in-vitro diagnostics.
Possesses full-cycle capabilities spanning regulatory approvals, quality
management, technical operations, and commercialization
- At Novomics, led regulatory affairs for Korea’s first officially
designated Innovative Health Technology (nProfiler® 1 Stomach Cancer
Assay), and oversaw licensing of AI-powered pathology diagnostic
software (nProfiler® OlivA G)
- Managed KGMP and ISO 13485 quality systems for IVD devices and software.
Successfully executed large-scale, multi-institutional clinical
performance studies involving over 2,000 gastric cancer patients
- Drove institutional certifications such as Innovative Medical Device
Company and Clinical Performance Testing Institution, and obtained
multiple national technology accreditations including NET, Inno-Biz, and
MFDS Innovative Device designation
- Oversaw global IP portfolio across 43 countries, led technology
transfers and DHF management. Extensive experience in national R\&D
programs, corporate collaboration, KONEX listing, and technical due
diligence for IPOs
- Holds a combined MS/Ph.D. in Medical Science from Yonsei University and
a BS in Biotechnology from Yonsei University College of Engineering
- Tel: +82-2-3400-0826 Email:
jm.park@mdrex.co.kr
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Sujeong Yoo
Hongji Oh
- Specialist, medical device RA/MA/QA/BD, MDREX
- Previously worked at Novomics Co., Ltd. (Aug. 2019 – Mar. 2025),
where she led full-cycle regulatory and strategic tasks for innovative
in-vitro diagnostics and AI-based pathology software.
- Managed regulatory approvals for the world’s first gastric cancer
prognosis gene test (nProfiler® 1 Stomach Cancer Assay; IVD No.
17-865) and AI-based pathology diagnostic software (nProfiler® OlivA
G; IVD No. 24-320).
- Operated KGMP and ISO 13485 quality management systems for molecular
diagnostic devices and IVD software.
- Oversaw multi-center, prospective clinical performance studies,
including trials involving over 2,000 gastric cancer patients.
- Led multiple institutional certifications, including MFDS-designated
Innovative Medical Device Company, Clinical Performance Testing
Institution, and Pathology Testing Laboratory.
- Supported acquisition of national technology certifications such as
Innovative Medical Device designation (MFDS No. 18) and Inno-Biz
accreditation (R210105-01384).
- Contributed to IR and IPO activities including KONEX listing and
technical due diligence for regulatory and investment evaluations.
- Tel: +82-2-3400-0827 Email:
hj.oh@mdrex.co.kr
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Sojeong Park
- PRO, medical device RA/MA/QA/BD, MDREX
- Product Approval, KGMP Certification, Reimbursement Assessment
- Tel: +82-2-3400-0825 Email:
sj.park@mdrex.co.kr
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Sangheon Lee
- PRO, medical device RA/MA/QA/BD, MDREX
- Product Approval, KGMP Certification, Reimbursement Assessment
- Tel: +82-2-3400-0829 Email:
sh.lee@mdrex.co.kr
|
Semin Kim
- PRO, medical device RA/MA/QA/BD, MDREX
- Product Approval, KGMP Certification, Reimbursement Assessment
- Tel: +82-2-3400-0828 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.
