We are a proudly U.S. owned and operated company with our headquarters and a full-service manufacturing facility based in Pennsylvania. Utilizing our 30-plus years in business and global resources, we offer additional manufacturing options in lower cost countries.
We built our first ISO Quality System in 1998 and were certified as meeting ISO 9002 standards in 1999. In 2005, we met ISO 13485 standards and became FDA Registered. We are currently ISO-13485:2016 certified 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.
FDA Registered
Sanbor Medical is a U.S. Corporation with FDA registered contract manufacturing facilities.
View Sanbor Medical U.S. FDA Registration
View Sanbor Medical Xiamen FDA Registration
ISO-13485:2016
Sanbor Medical is Certified to ISO-13485:2016 standards.
FDA Field Inspected
Of the 1302 FDA CDRH inspected facilities in China from 1/1/2009-12/31/2019
Sanbor Medical is a U.S. Corporation with FDA registered contract manufacturing facilities.
View Sanbor Medical U.S. FDA Registration
View Sanbor Medical Xiamen FDA Registration
Sanbor Medical is Certified to ISO-13485:2016 standards.
Of the 1302 FDA CDRH inspected facilities in China from 1/1/2009-12/31/2019