Korean Good Manufacturing Practice inspection - high score!

As a manufacturer, Sivantos Korea must undergo a Korean Good Manufacturing Practice (KGMP) inspection every three years. This important certification is comparable to the ISO13485 certificate for quality management and ensures medical device manufacturers comply with country regulations.

Recently, it was that time for the inspection again. We’re happy to report that during the 2018 inspection, there have been zero negative findings in our Korean quality management system (QMS). The inspector even said that Sivantos has “one of the top QMS in the medical device industry in Korea.”

This outstanding result is a great example of our high-quality production, not just in Korea but in all locations around the globe.



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