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: +82-2-2054-3455 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. 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
- 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
- CJO(Chief Japan Officer), 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
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Jungmin Park. PhD
- Senior Manager, 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: +82-2-2054-3401 Email: jm.park@mdrex.co.kr
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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
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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
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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.