FMI Expands Medical Silicone Rubber Manufacturing to China - Opens ISO Class 7 Cleanroom

FMI spent three years developing and validating its ultra-clean manufacturing capabilities in Suzhou, China. FMI is now taking orders from new and existing clients who wish to expand manufacturing outside the U.S.

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medical silicone molding
In China, we invested in a truly state-of-the-art 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.

Chicago, IL (PRWEB) June 05, 2014

FMI, a leading medical silicone molding manufacturer, announced the official opening of their ultra-clean manufacturing facility in Suzhou, China. The company has built a state-of-the-art ISO Class 7 cleanroom for medical device manufacturing as an addition to a facility owned and operated since 2004 by their parent company, Flexan Corporation. FMI specializes in manufacturing critical parts made of molded silicone rubber 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 state-of-the-art cleanroom 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.”

About FMI Medical Silicone Molding
FMI is a leading supplier of medical-grade silicone components designed primarily for use in implantable Class II and Class III medical devices. Since 1989 FMI has been helping medical device manufacturers develop new products and expand their global market reach. FMI opened its manufacturing facility in Suzhou, China in 2010. Both facilities are ISO 13485-certified for medical devices with Class 5, 6 and 7 cleanrooms in the US and Class 7 cleanrooms in China. FMI is a wholly owned subsidiary of Flexan Corporation, which began operations in 1946 in Chicago and also has a facility in Suzhou China which opened in 2004.


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