Registration complements the existing FDA registration and licence by the California Food and Drug Branch for design and manufacturing of medical devices
Aubrey, a developer of medical equipment and a contract manufacturer, reports that it is now 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 licence 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, 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 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 specialises in cardiovascular, blood processing, core temperature control, and patient monitoring applications.
It is located in Orange County, California.
