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We built our first ISO Quality System in 1998 and were certified as meeting ISO 9002 standards in 1999. In 2005, we became TUV Certified having met ISO 13485 standards and became FDA Registered. We are currently UL certified to ISO-13485:2016 standards and our quality system is QSR compliant and fully adheres to the 21 CFR Part 820 regulations. We are rigorously audited by leading global medical device companies on a routine basis.
Sanbor Medical is a U.S. Corporation with FDA registered contract manufacturing facilities.
Sanbor Medical is UL Certified to ISO-13485:2016 standards through June 26, 2025.
Of the 1302 FDA CDRH inspected facilities in China from 1/1/2009-12/31/2019