[MDREX NEWSLETTER] MDREX Expands Team: Senior Manager, an...
MDREX Expands Team: Senior Manager, an Expert in IVD and AI-based Diagnostic Software
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Greetings from MDREX.
To deliver more in-depth and strategic regulatory and reimbursement solutions in the field of in vitro diagnostics (IVDs) and medical products, MDREX has newly appointed Senior Manager Mr. Jungmin Park, a hands-on expert with deep practical experience.
Mr. Park holds a bachelor’s degree in biotechnology from Yonsei University’s College of Engineering and completed his master's and doctorate degree at the Graduate School of Medical Science, Yonsei University College of Medicine. He is a seasoned professional with a science and engineering background, who served as head of R&D, RA, QA, and MA teams for nearly a decade at Novomics Inc., a pioneering company in IVD and AI-based diagnostic solutions. His key accomplishments include the following:
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· Spearheaded the regulatory approval and the first-ever designation of Korea’s Innovative Health Technology for “nProfiler® 1 Stomach Cancer Assay”, the world’s first genetic test for gastric cancer prognosis.
· Successfully obtained regulatory approval for “nProfiler® OlivA G”, an AI-based pathological diagnostic software for gastric cancer.
· Created and operated quality systems required under KGMP and ISO 13485 standards (molecular diagnostic devices and IVD software).
· Conducted numerous clinical performance studies, including large-scale, multicenter clinical trials.
· Obtained institutional certifications and technology certifications, including Innovative Medical Device Company, NET (New Excellent Technology), Inno-Biz, etc.
· Managed global intellectual property rights, technology transfer, and Design History File documentation.
· Possesses hands-on experience in national R&D programs, industry collaborations, investor relations, and IPO preparation.
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With the addition of Mr. Park, MDREX is now able to provide even stronger support for regulatory affairs, clinical trials, reimbursement strategies, and global certification in the IVD and AI diagnostic software sectors.
Equipped with unmatched expertise and in-depth consulting, MDREX remains firmly committed to support your market entry and growth.
Thank you.
Best regards,
MDREX Co., Ltd.
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1315-ho, B-dong, 167, Songpa-daero, Seoul, Korea
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