Hiemstra Approved to Manufacture Medical Devices in New CER Meeting
SAN FRANCISCO, Jan. 9 /PRNewswire/ -- Hiemstra Product Development, a leading product design and development company, announced today that it has received Food and Drug Branch (FDB) approval from the California Department of Health Services' Division of Food, Drug and Radiation Safety to manufacture class I - III medical devices in its 750 sq. ft., class 10,000 CER (clean room). 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.
This 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. A few examples of the types of devices that Hiemstra's state-of-the-art CER can support are implants, surgical tools, catheters and catheter-based delivery systems.
"Now, Hiemstra is better equipped to increase speed-to-market by offering not only leading product design and development, but also manufacturing, in a one-stop-shop facility," noted Patrick Owens, Director of Operations at Hiemstra. "Our CER provides the flexibility to manufacture a few hundred to 30,000 units depending on the medical technology."
The engineering team at Hiemstra maintains in-depth knowledge of manufacturing processes to provide clients with additional support to ensure appropriate production resources are selected and to ensure a smooth transition to a high-volume production facility, as needed.
About Hiemstra:
Hiemstra Product Development is a leading medical product design and development company. Founded in 1991, this San Francisco-based firm is built on its unparalleled integration of industrial and mechanical design, with a unique focus on usability and rapid commercialization. Hiemstra's veteran team's experience spans a broad range of clinical areas and applications, and clients include start-ups to Fortune 500 companies. A portfolio and description of services can be found at http://www.hiemstra.com.
About Food and Drug Branch:
The Food and Drug Branch mission is to protect and improve the health of all California residents by assuring that foods, drugs, medical devices, cosmetics and certain other consumer products are safe and are not adulterated, misbranded nor falsely advertised; and that drugs and medical devices are effective. For more information, visit: http://www.dhs.ca.gov/fdb/.
CONTACT: Doug Hiemstra of Hiemstra Product Development, +1-415-495-6441,
ext. 109, 1-888-400-3374, dmh@hiemstra.com
Web site: http://www.hiemstra.com/