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

Congratulations! BPUMP successfully passed the audit of the Korean Ministry of Food and Drug Safety (MFDS) and KTR, and obtained Korean Class II Medical Device Quality System (KGMP) certification!

In late May 2023, Korean MFDS and KTR audit experts visited BPUMP to carry out a four-day 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 laboratory quality and technical records, on-site questions, etc.

In the evaluation process, the audit specialist gave highly praised and fully affirmed to the system of BPUMP: the document system is sound, the records are complete,and it complies with the accreditation standards,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.