Rose Technologies earns ISO 13485:2003 Certification Upgrade 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.

Grand Rapids, Michigan (Jan 2013) – 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, Rose Technologies forecasts 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,” said Todd Grimm, Rose Technologies President. “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.

Rose Technologies also announces 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. According to Grimm, “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.”  “We want the market to know we are ISO 13485 certified and have over 30% more production capacity. We are the Single Source Custom Medical Device Manufacturer that will partner with our customers to produce their devices on specification, on time, and on budget,” said Craig Finkel, Rose Technologies Director of Sales & Marketing.

About Rose Technologies
Rose Technologies is an ISO 13485 certified  and FDA Registered contract manufacturer of medical devices based in West Michigan that specializes in device manufacturing development and automation, pad printing, hole punching, catheter tipping, dip molded silicone balloon cuffs, wire reinforced silicone cannulae, forming and bonding of catheters & dilators, assembly and packaging services to support the global medical device industry.  Rose Technologies is recognized for its expertise in engineering designassistance for manufacturability, material selection and compliance to quality standards.  Find more information about Rose Technologies solutions at www.rose-technologies.com

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