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McLean, VA (November 15, 2007) – QinetiQ North America announced today that two of its subsidiary Foster-Miller’s engineering groups, the Commercial Equipment Group (CEG) and the Electronic and Electrical Systems Group (EES), have received international certification for quality management systems through ISO 13485:2003. By meeting ISO 13485 guidelines, Foster-Miller demonstrates that its medical device design and development processes meet objective quality standards. Certification also confirms the company’s ability to develop medical devices within compliance specifications. “In the very regulated and competitive medical industry, it is critical that medical device companies employ the most stringent quality standards,” says Robert Andrews, Medical Division Manager, CEG, Foster-Miller. “When designing and developing life-saving medical devices for our clients, we have always followed strict quality mandates. With ISO 13485 certification, we now have a global stamp of approval on our quality management systems, and this adds the level of trust and assurance that our customers require.” The standard, entitled “Medical Devices -- Quality Management Systems -- Requirements for Regulatory Purposes,” is a voluntary guideline used to assess whether companies have the appropriate quality controls in place to develop safe and effective medical devices. To meet ISO 13485 standards, medical device companies must demonstrate the establishment of processes for continuous monitoring and review of quality management systems and suitable procedures for regulating and controlling products. Additional requirements include documenting and validating processes for sterile medical devices, creating requirements for corrective and preventive actions and promoting consistent product safety in the work environment. “We are pleased to announce our ISO 13485 certification as objective confirmation of our rigorous internal quality control process,” says Edward Goldman, Senior Vice President, Foster-Miller. “We will continue to develop devices with compliance in mind to help our customers accelerate products through regulatory evaluation and to market.” About Foster-Miller Foster-Miller, Inc., now a part of QinetiQ North America’s Technology Solutions Group, is a technology and product development company with an international reputation for delivering innovative products and systems that perform under the most demanding conditions. The firm was founded in 1956 by three graduates of MIT who believed there was a need for a company that could solve clients' difficult technical problems through first-class analysis and design. Foster-Miller is certified to Aerospace Quality Management Standard AS9100 and has SW-CMM Level 3 software certification from the Software Engineering Institute at Carnegie Mellon University. In November 2004, Foster-Miller became a wholly owned subsidiary of QinetiQ North America. Visitwww.foster-miller.comfor further information.
About QinetiQ North America
QinetiQ North America provides world-class technology and responsive solutions to U.S. government customers. More than 5,300 engineers and technologists work in partnership with customers to develop innovative technology solutions to meet the challenges of national defense, homeland security and information access. QinetiQ North America is part of QinetiQ Group plc, one of the world’s leading defense and security technology companies. For more information, please visitwww.QinetiQ-NA.com. Return to Press Releases
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