Accellent Receives ISO 13485:2003 Certification; New Standard Marks Quality in Medical Device Market
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[July 21, 2005]

Accellent Receives ISO 13485:2003 Certification; New Standard Marks Quality in Medical Device Market

NEWTON, Mass. --(Business Wire)-- July 21, 2005 -- Accellent Inc., a medical device company offering integrated contract manufacture and design to the medical device industry, has received company-wide certification to ISO 13485:2003. ISO 13485:2003 is the certification standard specifically for the medical device industry. Achievement of ISO certification marks a corporate commitment to quality in the design and manufacture of medical devices that spans all levels in an organization.



"Accellent maintains a single, unified, world-class quality system focused on continuous improvement and zero defects," states Ron Sparks, Accellent's President and Chief Executive Officer. "This certification demonstrates our on-going commitment to providing the highest quality products and services to our medical device clients."

ISO, the International Organization for Standardization, is a worldwide federation of national standards bodies created to set standards for similar technologies in different countries. Achievement of ISO 13485:2003 demonstrates Accellent's dedication to continuously improve product quality and reliability; monitor health, safety and environmental protection; provide greater compatibility and interoperability of goods and services; and increase distribution efficiency.



"Quality is of the highest importance to our customers, and every Accellent employee understands the patient-critical nature of our customers' products," adds Sparks. "This certification recognizes our dedication to quality and patient efficacy. Accellent continues to deliver a quality program that meets or exceeds our customers' stringent requirements."

About Accellent

Accellent Inc., through its wholly owned subsidiary Accellent Corp., provides fully integrated contract manufacturing and design services to medical device manufacturers in the cardiology, endoscopy and orthopaedic markets. Accellent has broad capabilities in design & engineering services, precision component fabrication, finished device assembly and complete supply chain management. This enhances customers' speed to market and return on investment by allowing companies to refocus internal resources more efficiently. Our strategic intent is to be, as ranked by our customers, the world's best and most innovative order fulfillment and design organization to the medical device industry. For more information please visit www.accellent.com

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