Press Release

Nu Visions Manufacturing, LLC Awarded ISO 13485:2003 Medical Certification

SPRINGFIELD, Mass.-May 26, 2006- Nu Visions Manufacturing, LLC, a leading ISO-certified contract electronics manufacturer, has been awarded ISO 13485:2003 medical certification. The certification specifies requirements for a quality management system to demonstrate the ability to provide medical devices and related services that consistently meet customer and regulatory requirements. The scope of this quality management system includes production, assembly and repair of electronic systems.

"Nu Visions continues to confirm its commitment to quality through ISO certifications and regulatory compliance in our manufacturing facilities in the United States and Mexico," said Dan Perez, President and CEO, Nu Visions Manufacturing, LLC. "Our medical device customers can feel confident that Nu Visions shares their quality goals and meets or exceeds all regulatory requirements while continuing to provide innovative, cost-effective production solutions."

The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001. All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.

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