SUZHOU, China—FMI Inc., a subsidiary of Flexan Corp., has opened an ISO Class 7 cleanroom for medical device manufacturing in China.
The cleanroom is an addition to Flexan's Suzhou facility, which has been in operation since 2004.
FMI specializes in manufacturing parts from molded silicone rubber for implantable and disposable medical devices, surgical devices, lab equipment and medication delivery systems.
“Five years ago, our medical device original equipment manufacturer clients were telling us that they wanted to grow their manufacturing and marketing to emerging markets in Asia and India,” said FMI President Frank Sullivan.
FMI said it spent three years developing and validating its ultra-clean manufacturing capabilities in China and began shipping products from there in 2013.