Quality System
Our Xiamen, China factory continues to be at the leading edge of Offshore Manufacturing Facilities in the adoption of medical device industry quality standards. We built our first ISO Quality System in 1998 and achieved ISO 9002 certification in 1999. In 2005 we became ISO 13485 Certified. That same year we became FDA Registered. The factory is QSR compliant and fully adheres to the 21 CFR Part 820 regulations including for DHR and DMR maintenance.
