Hiemstra Product Development, San Francisco, Calif., a leading
product design and development company, 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.
For more in information, visit http://www.hiemstra.com or call
415/495-6441, ext. 109 or 888/400-3374.
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/.
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