Medical Device KGMP and Quality Management System Consulting

MISSION-DRIVEN

GMP Certification

The process of selecting business partners and concluding contracts is one of the crucial decisions that can determine the success or failure of a company. BCG recognizes this importance and provides due diligence services to identify the strengths, weaknesses, or risks of partners in advance, and supports the entire partner selection process, including contract review.

Moreover, BCG provides gap analysis services to thoroughly understand customer requirements and assist in achieving the best results in collaboration with partners. This ensures efficient cooperation with clients, minimizing resources and time invested in projects, and more reliably supporting the achievement of project goals.

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Manufacturing and Import GMP Certification

BCG provides professional consulting services to help medical device manufacturers and importers successfully obtain the GMP (Good Manufacturing Practice) certification required for product sales. We systematically support all stages of the GMP certification process, including the establishment of Quality Management Systems (QMS) and communication with manufacturers.

Quality Management System (QMS) Setup

BCG specializes in designing and establishing quality systems that meet domestic and international regulatory requirements for successful business operations and regulatory compliance. Based on global standards such as the Korean MFDS regulatory requirements, ISO 13485 (Medical Device Quality Management System), and the U.S. FDA's 21 CFR, we offer customized quality systems. During the setup process, BCG designs a system optimized for the client's organizational structure and operational methods, providing practical documentation and processes. This ensures that clients meet regulatory requirements efficiently and establish a reliable quality management system for internal and external audits.

Mock Audits

BCG offers mock audit and gap analysis services. Our audit services thoroughly evaluate partners' regulatory compliance and quality management status according to the required international standards (ISO 9001/13485, US CFR, etc.). This allows clients to identify the strengths, weaknesses, and potential risks of their partners in advance, helping to establish reliable partnerships. The scope of BCG's audits includes medical device and pharmaceutical manufacturers, third-party testing organizations (CROs), external warehouses (3PLs), and more. Through this, clients can ensure quality and regulatory compliance across their entire supply chain.

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