Aubrey Group Announces ISO 13485 Certification

November 19, 2004 (PRLEAP.COM) Health News
IRVINE, Calif., - Aubrey Group, Inc., a developer of medical equipment and a contract manufacturer, announced today that it is a UL Registered Firm and has been certified as meeting ISO 13485 (medical device) and ISO 9001 standards by Underwriters Laboratories. This registration complements the existing FDA registration and license by the California Food and Drug Branch for design and manufacturing of medical devices.

"This completes the second stage of our strategic plan to grow our business by adding contract manufacturing,' said Vytas Pazemenas, the President and Founder of Aubrey Group. "We are now able to self-certify Class I devices for CE compliance, and complete Class II and III certification with final inspection by our Notified Body.' Since many original equipment manufacturers launch their products in Europe, CE mark is essential.

In addition to medical product development, Aubrey Group will now offer product-focused contract manufacturing that complies with FDA Regulations and the ISO 13485 standard.

The company develops and manufactures complex electronic and electromechanical medical instruments for start-up and established companies and specializes in cardiovascular, blood processing, core temperature control, and patient monitoring applications. It is located in Irvine, Orange County, California.

For more information please visit www.aubreygroup.com

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FOR IMMEDIATE RELEASE – Aubrey Group, Inc., 217 Technology Drive, Suite 100, Irvine, CA 92618. www.aubreygroup.com CONTACT: Steve Maylish, Director of Business Development, Aubrey Group Inc. (949) 727-0188, stevem@aubreygroup.com or Joanna Laznicka of Phaze-9 Corporation
(408)245-5117, joanna@phaze-9.com



High resolution photo available at:
http://www.phaze-9.com/PressPictures/AubreyGroup2.jpg
Photo Caption - Aubrey Group assisted in the development of the DV2 Perioscopy™ System for DentalView, Inc. in Irvine, CA. The DV2 Perioscopy ™ System integrates a miniature fiberoptic endoscope and disposable sheath with a medical-grade CMOS camera, digital processor and flat panel video monitor that captures and displays real-time images. This system allows dentists and hygienists to perform subgingival diagnostic and therapeutic procedures.