For Immediate Release

ALEXANDRIA, Minn. – Donnelly Custom Manufacturing today announced it is pursuing the ISO 13485 Quality Standard for medical devices regarding regulatory requirements and device safety.

“Medical Device OEMs continue to demand the highest quality parts from their suppliers, and this certification is the industry standard, which adds significant credibility to our capabilities,” said Sam Wagner, director of advanced manufacturing at Donnelly Custom Manufacturing. “Donnelly strives to exceed expectations set by our customers.”

Donnelly Custom Manufacturing anticipates receiving the ISO 13485 Certification by fall 2006.

“Given our focus on Short-Run Manufacturing, we need to be terrific at launching molds into production,” said Ron Kirscht, president at Donnelly Custom Manufacturing. “We believe this certification serves as a platform for gaining continued improvements to our quality management system, and maintaining high levels of customer satisfaction.”

“Over the next several months, we will be fine-tuning our procedures for medical devices as we assess and determine action items for new and existing projects,” added Wagner. “Our commitment is to know our customers and tailor solutions to the toughest manufacturing challenges facing their business.”

Based in Alexandria, Minn., Donnelly’s 230 employees are dedicated to setting the standards in the custom injection-molding marketplace for “How Short Run Is Done.” The company’s focus is on providing its OEM customers with value added engineering, and highly customized manufacturing and customer support services.  A strong customer service orientation ensures outstanding customer satisfaction.
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