Obtained Korean Class II Medical Device Quality System (KGMP) certification!

In middle March, 2026, Korean MFDS and KTR audit experts visited BPUMP to carry out a four-days comprehensive audit work. The scope of the on-site review includes quality management system operation, personnel technical ability, organizational setup, environmental facilities conditions, instruments and equipment configuration, etc., the review methods include field test, access to management system documents, spot check quality and technical records, on-site questions, etc.
During the review process, the audit specialist gave highly praised and  fully affirmed Pump Medical's system: its documentation system was comprehensive, all records were complete, it met accreditation criteria. The quality management system meets the requirements of Korean Medical Device Manufacture and Quality Management Regulation and IS013485 . After a detailed and professional review and inspection by the review experts, it was unanimously agreed that BPUMP has passed the on-site review.