Our CEO.
Professional Background & Message
- More than 15 years of experience in medical device and pharmaceutical quality assurance (QA) and regulatory affairs (RA)
- Previously served in Director of Quality roles at Novavax, MSD/Merck, SK and GE Healthcare
- Lead auditor for cGMP and ISO 13485 with Qualifyze GmbH (Europe) and SQA Services Inc. (US)
- ASQ Certified Quality Engineer (CQE)
- Master's degree in biomedical convergence; bachelor's degree in biomedical engineering
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The medical device industry is shaped by constant advances in technology and evolving regulatory requirements. BCG develops practical solutions to help clients comply with domestic and international regulations and bring safe, innovative products to market.
We aim to be a trusted partner through specialist consulting in device registration, KGMP certification, registration renewal, reimbursement listing and GxP language services. Regulatory compliance and quality management are central to our clients' credibility and competitiveness, and we approach every project with expertise and accountability.
We believe that our clients' success is our success. We respond proactively to regulatory change and work alongside our clients as their businesses grow. We are committed to providing dependable support as a long-term partner.
Jimin Choi, Principal Consultant, BCG Inc.