FMI is dedicated to producing medical-grade silicone components for Class II and Class III medical devices. In fact, custom silicone moldings are the only products we manufacture and health care is the only industry we serve. That singular focus allows us to provide the highly customized components that medical device manufacturers depend upon for patient safety, efficacy and reliability. Since 1989, we have been supplying micro-precision molded components to leading medical device manufacturers and helping them expand their global market reach. We understand the intricacies of FDA requirements and global manufacturing standards and we aim to exceed them with our ultra-clean silicone molding facilities. Our Chicago area headquarters and offshore manufacturing facility in Suzhou, China are both ISO 13485-certified with Class 5, 6 and 7 clean rooms. We work with our clients to speed products to market through our rapid development program, while maintaining the highest quality and competitive pricing. FMI Medical is a privately held company, owned by Flexan Corporation, founded in 1946, with more than 500 employees worldwide.