Hiemstra receives approval to manufacture medical devices

Hiemstra Product Development, a product design and development company has received Food and Drug Branch approval from the California Department of Health Services’s Division of Food, Drug and Radiation Safety to manufacture class I - III medical devices in its 750 sq. ft., class 10,000 CER.

This Food and Drug Branch (FDB) approval enables Hiemstra to be a valuable manufacturing resource for customers through first-in-man, ongoing clinical trials, and low-to-mid volume production needs during early ramp-up or as ongoing manufacturing support.

Hiemstra can now help customers bring their medical technologies from concept to clinical release faster than before by offering world class product design and development, as well as manufacturing services, all under one roof.

Patrick Owens, director of operations at Hiemstra, said: “Our CER provides the flexibility to manufacture a few hundred to 30,000 units depending on the medical technology.”