Professional Background and Greeting

  • With over 15 years of experience in Medical Device/Pharmaceutical QA and RA
  • Former Director of Quality at Novavax, MSD/Merck, SK, GE Healthcare, etc.
  • Lead Auditor for cGMP and ISO13485 at Qualifyze GmbH (Europe) and SQA Services Inc. (USA)
  • Certified Quality Engineer (CQE) by ASQ (American Society for Quality)
  • Master's in Biomedical Convergence and Bachelor's in Biomedical Engineering

I sincerely thank everyone who has visited the BCG website.

The medical device industry is a dynamic field with constantly evolving technological innovations and regulatory requirements. In this environment, BCG strives to provide optimal solutions to help our clients comply with domestic and international regulatory requirements, and bring safe and innovative products to market.

Through our comprehensive consulting services in medical device approvals, GMP certifications, product renewals, reimbursement listings, and GxP translation, we aim to be a partner in our clients' success. We understand that regulatory compliance and quality management are key factors in gaining trust and securing market competitiveness, and we are committed to providing these with professionalism and responsibility.

BCG will continue to proactively respond to the ever-changing regulatory environment and grow alongside our clients based on our belief that "our success is the success of our clients." We promise to continue providing the best services as your valuable partner.

Jimin Choi, CEO

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