About Us.
Medical Device & IVD Consulting
ONE STOP,
WE DON’T STOP
BCG is a Korean consulting firm specialising in medical devices and IVDs. We help manufacturers and importers meet complex regulatory requirements and compete in global markets.
Drawing on practical experience with MFDS requirements, ISO 13485 and US FDA regulations under 21 CFR, we develop solutions tailored to each client's needs.
Why BCG
Expertise
EXPERTISEOur consultants bring extensive experience from Korean and international companies. We offer practical advice and options to help clients navigate complex regulatory requirements and enter the market.
Commitment
ENTHUSIASTICOur specialists take an active approach to problem-solving, using on-site visits, in-person meetings, video calls and other effective forms of communication.
Efficiency
EFFICIENTWe value our clients' time and resources and seek practical, cost-effective ways to achieve project goals.
BCG Services
Our services cover medical device manufacturing and import business licences, KGMP certification, product registration and renewal, reimbursement listing, local representation, and GxP translation and interpreting.
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