With a seasoned team of USA medical device manufacturing professionals along with the best Quality Systems in Asia, we take quality seriously.
Our manufacturing partners are ISO 13485 Certified, and/or have FDA registration (when needed). Anyone in the medical device business knows, Quality is a must have or as we say a “ticket to entry”. From complete validations and protocols, to FAI’s, we provide a full suite of Quality solutions to fit the unique needs of each component, device and class of product. (from Prototypes to FG Medical Devices)