Proven Partners in Custom Silicone Medical Component Manufacturing
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 for Long Term Implantables, Short Term Implantables, Disposables, and Silicone Extrusion 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. Our goal is to exceed all requirements and standards, which is why we built a new 20,000 square foot Class 7 cleanroom located at our global headquarters in Lincolnshire, IL.
Our Salt Lake City area facilities are ISO 13485-certified, FDA Registered with Class 8 Cleanrooms while our offshore manufacturing facility in Suzhou, China is ISO 13485-certified with Class 7 Cleanroom and is a Wholly Foreign Owned Enterprise of Flexan, LLC.
We work with our clients to speed products to market through our rapid development program and engineering expertise while maintaining the highest quality and embracing our Lean Six Sigma methodologies.
FMI Medical is a privately held company, owned by Flexan LLC, founded in 1946, with nearly 800 employees worldwide.