Flexan LLC, a provider of custom contract manufacturing services, has announced the registration of its manufacturing facility in Suzhou, China with FDA. It is the company’s 4th FDA registered location and will enable the company to expand its manufacturing solutions for Class II and Class III medical devices. Flexan has also successfully registered its first full finished device, which will begin production in Suzhou in early 2021, the company reported.
Flexan established operations in Suzhou in 2004 and has since expanded its services to provide cleanroom manufacturing for short- and long-term medical devices and components, supporting its global customer base. In addition to operating a fully integrated manufacturing platform, the company provides centers of excellence in manufacturing solutions for silicone, thermoplastic, and custom rubber formulations.
“This registration represents another effort by Flexan to meet the needs of our global customer base and support their desire for high-quality, cost-competitive medical devices," said Mike Huiras, Flexan vice president of sales and marketing. "We are confident that our dedicated team in Suzhou is prepared to support our first full device production program, along with additional new business we expect to support in Suzhou in the future. Our experience operating in China for nearly 2 decades has prepared us for this next stage in our growth as a global services provider.”