FMI, a medical silicone moulding manufacturer based in Elk Grove Village, Illinois, US, has officially opened its 6,000ft2 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 its parent company, Flexan Corporation.
FMI specialises in manufacturing critical parts made of moulded silicone rubber for implantable and disposable medical devices, surgical devices, lab equipment, and medication delivery systems.
The company 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 Suzhou facility is now taking orders from clients who wish to expand manufacturing outside the US.
'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 US manufacturing practices and innovations. Our goal is to offer a low-cost country option with the same stringent quality systems.'
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.