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Source: 3C Communications on behalf of Unique Design

Unique Design Earns ISO 13485 Certification

SHELTON, CT (February 14, 2005) - Unique Design and Development, LLC has earned certification to ISO 13485:2003 and ISO 9001:2000 from BSI Management Systems (BSI). BSI is a world leader in the development, implementation and registration of management standards, assisting organizations to gain accreditation that reflects improved business performance.

The scope of Unique Design’s certification is the contract design and development of medical devices including surgical instruments and implants. The company’s product development expertise, FDA QSR and ISO systems, and prototyping and testing capabilities provide an option for clients to compliment and enhance in-house capabilities.

Steve Maguire, General Manger of Unique Design stated, “In developing our systems, we have integrated our business and quality processes in a way that affords thorough and customer-focused development, with no loss of innovation or speed to market. This certification, coupled with our extensive orthopedic experience, provides the confidence customers need to ensure the quality of their products.”

Unique Design, a wholly-owned subsidiary of Unique Instruments, Inc., is a full service contract orthopedic product design and development provider. Capabilities at a new, state-of-the-art facility in Shelton, CT, include Computer Aided Design (CAE), CNC Prototyping, and Biomechanical Testing. Customers range from multinational orthopedic corporations to venture capital start-up companies.

Additional information is available from:

Dennis Sullivan, Unique Design, 80 Shelton Technology Center, Shelton, CT 06484-6406, dsullivan@uniqueD.com, PH: 203.922.0105, FX: 203.922.0130 www.UniqueD.com