Navigation Links
Hiemstra Approved to Manufacture Medical Devices in New CER
Date:1/9/2008

Meeting medical clients' needs from product design and development through

manufacturing

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/.


'/>"/>
SOURCE Hiemstra Product Development
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. RNs Statement on Death of Nataline Sarkisyan: CIGNA Should Have Listened to her Doctors and Approved the Transplant a Week Ago
2. Pennsylvania American Waters Rate Case Approved
3. PEGINTRON(TM) and REBETOL(R) Approved in European Union for Retreating Hepatitis C Patients Who Failed Previous Pegylated or Non-Pegylated Interferon Therapy
4. Barrs Generic Version of Estrostep(R) Fe Tablets Approved
5. A fresh look at existing therapies: Researchers explore ways to teach approved drugs new tricks
6. Voltaren(R) Gel Receives US Regulatory Approval as the First Approved Topical Prescription Treatment for Pain Associated with Osteoarthritis
7. Optometry-Backed Vision Care for Kids Act Approved by U.S. House
8. Video: New FDA-Approved Sun Protectant Saves Skin All Year Round
9. FDA Cracks Down on Unapproved Cough Medicines
10. $52.5 Million Settlement Against Sepracor Inc. Approved
11. Ranbaxy Receives Final Approval to Manufacture and Market Cetirizine Hydrochloride Tablets (OTC), 5mg and 10mg
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/12/2016)... ... 12, 2016 , ... Fisher House Foundation Chairman and CEO Kenneth Fisher joined ... Support Alliance president Scott Bensing, and Peggy Kearns Director, VA Southern Nevada Healthcare System ... This will be the first Fisher House in Nevada, and will provide free ...
(Date:2/12/2016)... ... 12, 2016 , ... Erlanger Agency has announced a new partnership in its ... campaign focuses on the fight against breast cancer, fundraising for a local woman named ... . , Carmen is a loving single mother of two boys who also serves ...
(Date:2/12/2016)... Lakeland, FL (PRWEB) , ... February 12, 2016 , ... ... Coast Dental hygienist Suzan Sweeney, RDH, and dental assistant Terrell Moore shortly before 7 ... They joined dozens of dental professionals, donating their time and skills to help hundreds ...
(Date:2/12/2016)... ... February 12, 2016 , ... Atlantic Information ... Health Plans and PBMs,” an upcoming Feb. 24 webinar that will discuss ways ... big-dollar therapeutic categories, such as the $1,000-per-pill hepatitis C treatment Sovaldi and high-cost ...
(Date:2/12/2016)... , ... February 12, 2016 , ... Healthcare careers in ... five most searched jobs via the website of healthcare staffing leader Aureus Medical Group ... travel nurse jobs , travel therapy positions and in travel and direct ...
Breaking Medicine News(10 mins):
(Date:2/11/2016)... , Feb. 11, 2016  Kindred Biosciences, Inc. (NASDAQ: ... and improving the lives of pets, today announced the ... the New Animal Drug Application (NADA) for Zimeta™ (dipyrone ... study (KB0120) of Zimeta for the control of pyrexia ... --> --> The ...
(Date:2/11/2016)... 11, 2016   Health 2.0 , the premiere ... technologies, announced today " 10 Year Global Retrospective ", ... over the past ten years.   ... Health 2.0 has served as the preeminent thought-leader in ... thousands of technologies, companies, innovators, and patient-activists through an ...
(Date:2/11/2016)... 2016  MiMedx Group, Inc. (NASDAQ: MDXG ), ... and other birth tissues, human skin and bone, and ... advanced products and therapies, announced today that it will ... Conference in New York , NY.  ... J. Senken , Chief Financial Officer and Chris ...
Breaking Medicine Technology: