Navigation Links
Hiemstra Approved to Manufacture Medical Devices in New CER

Meeting medical clients' needs from product design and development through


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

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:

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:
(Date:10/13/2017)... , ... October 13, 2017 , ... Many families have ... many long-term care insurance companies have a waiver for care if the client has ... period, when the family pays for care, is often waived, so the benefits from ...
(Date:10/13/2017)... NJ (PRWEB) , ... October 13, 2017 , ... Global ... at scenic Alexandria Park in Milford, NJ. This free event, sponsored by Global ... physical activity. The fun run is geared towards children of all ages; it ...
(Date:10/13/2017)... ... 13, 2017 , ... Coveros, a leader in agile coaching ... contract by the Center for Medicare and Medicaid Services (CMS). The Enterprise Agile ... of Agile methodologies in a consistent and high value manner across CMS programs. ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... for healthcare compliance program management, will showcase a range of technology and learning ... Assisted Living (NCAL) Convention and Expo to be held October 14–18, 2017 at ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... meet the demand of today’s consumer and regulatory authorities worldwide. From Children’s to ... and tested to meet the highest standard. , These products are also: ...
Breaking Medicine News(10 mins):
(Date:9/22/2017)... , Sept. 22, 2017  As the latest ... Senators Bill Cassidy (R-LA) and Lindsey ... notes that the medical device industry is in an ... device tax, the 2.3% excise tax on medical device ... they also want covered patients, increased visits and hospital ...
(Date:9/18/2017)... Pa. and KALAMAZOO, Mich. , Sept. 18, ... , and OptiMed Specialty Pharmacy of ... to offer a strategic hub service that expedites and ... sought-after personal spirometer, Spiro PD 2.0, and wellness management ... spirometer is a medical device used to measure lung ...
(Date:9/12/2017)... N.J. , Sept. 12, 2017  Consumer reviews on the ... Hearing as the number one company for hearing aids, ranking ... and fifteen other brands. ... Embrace Hearing Named #1 by Consumers For Hearing Aids ... Embrace Hearing is an online store that provides high ...
Breaking Medicine Technology: