KGMP Certification.

We help medical device manufacturers and importers obtain certification under Korea's medical device manufacturing and quality management standards (KGMP). Our support covers each stage, including QMS development and coordination with manufacturing sites.

We design and implement quality systems tailored to our clients' operations and regulatory obligations. Our work draws on MFDS requirements, ISO 13485 and US FDA regulations under 21 CFR. We align the system with the client's organisational structure and processes, providing documents and procedures that can be used in day-to-day operations. This helps clients meet regulatory requirements efficiently and establish a reliable quality management framework for internal and external audits.

We provide mock audits and gap analysis against relevant standards and regulations, including ISO 9001, ISO 13485 and US CFR requirements. These assessments help clients understand a partner's compliance status, quality management practices, strengths, weaknesses and potential risks. Our audit scope includes medical device and pharmaceutical manufacturers, third-party testing and contract research organisations (CROs), and third-party logistics (3PL) warehouses, supporting quality and regulatory compliance throughout the supply chain.