Specialized RA & QA consulting for global manufacturers. Fast-track your medical devices and IVDs into South Korea with confidence and full regulatory compliance.
We provide flexible, contract-based solutions optimized for foreign manufacturers.
End-to-end management of MFDS submissions for Class I-IV medical devices and IVDs. Contracted on a per-registration basis to ensure dedicated focus.
Comprehensive guidance for Quality Management System implementation. We prepare you for rigorous on-site and documentary KGMP audits by Korean authorities.
Need quick answers? We offer cost-effective, rapid consultations for classification, strategic planning, or simple regulatory inquiries.
With over 20 years of dedicated experience in regulatory affairs and quality assurance, our team has a proven track record of navigating the complex Korean regulatory landscape for top global manufacturers.
Extensive experience with high-volume registrations including CT, MRI, PET, X-Ray, Interventional systems, Surgery C-arms, and standalone Medical Software.
Specialized in critical care and renal therapies (Class III-IV) including Hemodialysis & Peritoneal dialysis systems, Dialyzers, Water purification filters, Catheters for infusion/drainage, Fistula needles, and Cardiopulmonary bypass oxygenators.
Extensive expertise in IVD instruments (Coagulation analyzers, Blood gas analysis, Immunofluorescence) and reagents for autoimmune, histocompatibility, and blood grouping.
Successful MFDS registrations for various dental materials, surgical appliances, and general medical equipment.
Fluent in English and highly experienced in communicating with foreign HQs and local authorities like the MFDS and NIDS.
Contact us today to discuss your medical device portfolio and regulatory needs.