Quality System

The Quality Management System (QMS) at Ximedica has been built from the ground up to reflect the unique service that we provide our clients.
 
We formed a team of content experts, human factors engineers and information architects who continuously work alongside our Quality and Regulatory personnel to develop a QMS that marries the rigors of the FDA with lean development best practices. The system has also been designed to be easily updated and with consideration for maximum cognition.

Ximedica is ISO 13485:2003 certified and FDA registered, as both a specification developer and contract manufacturer to support our product introduction capability.

All Ximedica employees receive regular training and we are audited regularly by our Notified Body, as well as by clients and vendors alike. In many cases projects utilize our QMS through all product development phases.