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Rose Technologies Earns ISO 13485 Certification

Manufacturing Group | January 31, 2013

Expands Clean Rooms and Capabilities for Packaging of Medical Devices

Contract medical device manufacturer Rose Technologies has successfully completed the rigorous requirements necessary to achieve additional ISO 13485 certification for assembly, packaging, and sterilization of medical devices. The capability of start-to-finish manufacturing of a broad array of medical products opens a new market sector for the company.

Building on the company’s strong sales growth in 2012, analysts for Rose Technologies forecast an additional significant double digit growth in 2013 fueled by these new capabilities.

“Expanding our ISO certification will put us in a position to potentially double sales in the next three to five years, as the market recognizes our added capabilities,” says Todd Grimm, president, Rose Technologies. “The addition of final assembly, packaging and sterilization is a natural extension to our existing capabilities. Previously we were a component supplier aligned with a few core competencies. Many of our customers, who may not have manufacturing capabilities, asked us to provide additional assembly services for them. With this ISO upgrade, we are now able to seamlessly provide those services and meet customer needs.”

This certification comes on the heels of the launch of a new endotracheal device manufactured and packaged by Rose Technologies. Future sales efforts will focus on finished devices for customers who are advancing products for cardiovascular, cancer, orthopedic, bariatric, neurology and other therapies.

Officials for the company also announce the completion and certification of an additional ISO-14644 Class 7 clean room. Like Rose Technologies’ existing clean rooms, the new room features a HEPA filtration system, temperature controls, and strict quality compliance procedures, as well as more than 30% more production capacit

“Our greatest priority is delivering quality compliance at every step of the manufacturing process.  The new Class 7 clean room is part of our commitment to helping our customers meet their specific quality requirements for their medical devices," says Grimm.

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