FDA Registered Facilities

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 Cut Costs — Not Corners

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.

FDA Registered

Sanbor Medical is a U.S. Corporation with FDA registered contract manufacturing facilities.

View our FDA Registrations

View Sanbor Medical U.S. FDA Registration
View Sanbor Medical Xiamen FDA Registration
View Sanbor Medical Malaysia FDA Registration

ISO-13485:2016

ISO Certificate 2022

UL Certified

Sanbor Medical is UL Certified to ISO-13485:2016 standards through June 26, 2025.

View UL Certificate

FDA Field Inspected

medical pills industry factory and production indoor-2

FDA Field Inspected

Sanbor Medical's quality system is QSR compliant and fully adheres to the 21 CFR Part 820 regulations. We routinely pass rigorous audits by some of the leading medical device companies in the world.

FDA Registered

Sanbor Medical is a U.S. Corporation with FDA registered contract manufacturing facilities.

View our FDA Registrations

View Sanbor Medical U.S. FDA Registration
View Sanbor Medical Xiamen FDA Registration
View Sanbor Medical Malaysia FDA Registration

ISO Certificate 2022

UL Certified

Sanbor Medical is UL Certified to ISO-13485:2016 standards through June 26, 2025.

View UL Certificate

FDA Field Inspected

Sanbor Medical's quality system is QSR compliant and fully adheres to the 21 CFR Part 820 regulations. We routinely pass rigorous audits by some of the leading medical device companies in the world.

Smarter Manufacturing Starts Here.

Connect with our team to learn how a Sanbor Medical partnership is the future of medical device contract manufacturing.