About Us

BCG is a leading consulting company in South Korea, specializing in medical devices and in-vitro diagnostic devices. We assist medical device manufacturers and importers in meeting complex regulatory requirements and competing successfully in the global market. With a deep understanding and practical experience of various domestic and international regulatory standards, including the Ministry of Food and Drug Safety (MFDS) in Korea, ISO 13485, and the U.S. FDA's 21 CFR, we provide tailored solutions based on the specific needs of our clients.

BCG offers comprehensive professional services across the entire medical device industry, including medical device manufacturing and import licenses, GMP certification, product approvals, product renewals, health insurance reimbursement listings, local representative services, and GxP translation. Each service is designed to align with the characteristics of the client's products and market, improving the efficiency of the approval process and ensuring the quality and safety of the products. We also analyze regulatory challenges in advance and provide solutions, helping clients successfully enter the market and operate their business.

BCG goes beyond simply meeting regulatory requirements; we support clients in achieving sustainable growth in the market. We systematically manage the entire process from the initial stages of each project to execution, audit responses, and post-management, saving clients time and cost. In particular, we quickly reflect the latest regulations and technological trends related to medical device approvals and offer the most suitable strategy for our clients.

BCG prioritizes understanding our clients' goals and providing services with professionalism and responsibility. As a partner based on trust, even in a complex regulatory environment, we work together with you to ensure your successful market entry and strengthen your competitiveness.

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Why BCG

Expertise

BCG is composed of professional consultants with extensive practical experience in domestic and foreign corporations. Based on this experience, we possess a deep understanding and expertise in medical device regulations, offering realistic cases and alternatives to help clients effectively navigate complex regulatory environments and successfully enter the market.

Enthusiastic

BCG is a group of professionals dedicated to solving problems with enthusiasm. We actively utilize all means of communication, including local trips, face-to-face meetings, and video conferences, to find the best alternatives for our clients' issues. We seek the fastest and most effective solutions for each situation, supporting our clients in overcoming complex challenges related to medical devices and achieving success in the market.

Efficient

BCG values our clients' time and cost. To efficiently achieve project goals, we seek the most economical and time-efficient solutions. For this, we thoroughly analyze our clients' needs and market conditions, applying optimized project management approaches. BCG's strategy focuses on maximizing value for clients while minimizing resource use. This approach helps clients save on costs and time, enhancing their competitiveness in the medical device sector.

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Partners, Clients

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  • (+82) 031-711-0685
  • 101-102, 660, Daewangpangyo-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
  • bcg@biocongroup.net