Contract Manufacturer has Expertise in Implantables

A vertically integrated contract manufacturer has expertise in implantable devices. The company can assist customers with product design and development and is experienced in molding, machining, and assembling custom devices. It also provides packaging and sterilization management services. ISO 9001:2008– and ISO 13485:2003–certified and FDA compliant, it employs manufacturing processes that are validated according to the quality system regulation in 21 CFR Part 820. A project-team approach ensures optimal component or product integrity. The firm’s service portfolio comprises design engineering, prototyping, rapid tooling, around-the-clock controlled-environment molding of engineered resins, and fabrication of close-tolerance precision components by means of milling, turning, and electrical-discharge machining.

Donatelle
New Brighton, MN, 651/633-4200