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.
In late 2009 we contracted with TUV to be our ISO registrar in order to be more fully aligned with the medical device industry, our exclusive customer base. Our most recent recertification was by UL effective November 2, 2018.
The Xiamen factory is a complete white room environment, complementing our high quality standards. Our quality system is QSR compliant and fully adheres to the 21 CFR Part 820 regulations for DHR and DMR maintenance.