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IQuum's Marlborough Facility Receives ISO 13485:2003 Medical Certification Marlborough, MA, July 11, 2007 – IQuum, Inc. announced today that its Marlborough, Massachusetts facility has received registration to ISO 13485:2003 for its Medical Device Quality Management System. This certification covers the design and development, manufacture and distribution of molecular diagnostic-based in vitro diagnostic (IVD) systems consisting of instruments, reagents and disposables. ISO 13485:2003 specifies requirements for quality management systems in which organizations demonstrate the ability to provide medical devices and related services that consistently meet both customer and regulatory requirements. Areas covered by the registration include design and process controls, documentation and records, manufacturing, customer service and support, and employee training. ISO 13485:2003 certification of the Company’s Quality Management System is considered to be fully compatible with the Quality System requirements of the US Food and Drug Administration (FDA). “This is an important step as IQuum moves to manufacture and commercialize its Liat™ Analyzer products.” said Dr. Shuqi Chen, CEO of IQuum. “Providing quality molecular diagnostic systems to our customers is our top priority, and we are very pleased to receive this internationally recognized certification.” IQuum has been developing its Quality Management System over the past year and, after relocation to its current Marlborough facility in September 2006, underwent and passed audit in early 2007. About IQuum, Inc. IQuum is the leader in developing lab-in-a-tube technology, a novel biological sample testing platform which provides revolutionary benefits to a broad cross section of the bioassay market. The Company's proprietary technology enables the non-specialized personnel to perform more sophisticated biological sample testing in any setting with greater speed. Founded in 1998, the Company is commercializing its lab-in-a-tube technology and products for the clinical diagnostics, bio-defense, and industrial testing markets. For more information, please visit www.IQuum.com.
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