Hiemstra Product Development has added a cleanroom to help its customers meet their product development and manufacturing needs. The San Francisco–based company recently received approval to manufacture Class I, II, and III medical devices in its Class 10,000 cleanroom.

With the approval, Hiemstra can provide additional resources for companies seeking support for clinical trials, low- to mid-volume production, or manufacturing.

“Hiemstra is now better equipped to [shorten] time to market by offering not only product design and development, but also manufacturing, in a one-stop-shop facility,” says Patrick Owens in a company statement. He is director of operations at Hiemstra.

The 750-sq-ft cleanroom supports devices such as catheters and their delivery systems, implants, and surgical tools. Depending on the medical product, the cleanroom provides the option of manufacturing volumes from a few hundred to 30,000 units.

The company's engineers can also help clients choose the appropriate resources when moving to a high-volume production facility.

Hiemstra is a product development firm that focuses on industrial and mechanical design, usability, and rapid commercialization. The company received the cleanroom approval from the Food and Drug Branch of the Cali­fornia Department of Health Services' Division of Food, Drug, and Radiation Safety.

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