FMI Inc. announced the official opening of their medical silicone molding manufacturing facility in Suzhou, China. The company has built the state-of-the-art clean room as an addition to the facility owned and operated since 2004 by their parent company, Flexan Corporation. FMI specializes in manufacturing silicone rubber components for implantable and disposable medical devices, surgical devices, lab equipment, and medication delivery systems.
FMI has spent three years developing and validating its ultra-clean manufacturing capabilities in the Suzhou facility and began shipping products from there to a multinational client last year. The FMI facility in Suzhou is now taking orders from new and existing clients who wish to expand manufacturing outside the U.S.
“Five years ago, our medical device OEM clients were telling us that they wanted to grow their manufacturing and marketing to emerging markets in Asia and India,” said Frank Sullivan, president of FMI. “In China, we invested in a truly innovative clean room that draws on everything we know from U.S. manufacturing practices and innovations. Our goal is to offer a low-cost country option with the same stringent quality systems.”
FMI meets the highest quality standards in global manufacturing for medical devices, as an ISO 9000:2008 and ISO 13485 registered company, providing clean room silicone molding in ISO Classes 5, 6 and 7, at its China facility and its U.S. headquarters in Elk Grove Village, Illinois. FMI is a wholly owned subsidiary of Flexan Corporation, which owns the manufacturing plant in the Singapore-China Suzhou Industrial Park, located about 60 miles from Shanghai.