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Rochester Medical Implants Achieves ISO 13485:2003 Certification for Medical Device Manufacturing


9/25/2008 6:20:31 AM

ROCHESTER, Ind., Sept. 25 /PRNewswire/ -- Rochester Medical Implants (http://www.rmi.us.com), a contract manufacturer of high-precision spinal and orthopaedic implants and instruments, announced today that it has achieved ISO 13485:2003 certification through auditor NSF International.

"Building upon our existing ISO 9001:2000 quality system, the ISO 13485:2003 certification process has been a major business initiative of our company and reflects the organization's commitment to manufacturing high-quality products for the medical device market," commented James K. Evans, President of Rochester Medical Implants. "Achieving this important objective sets RMI apart from many of our competitors and offers our customers a quality partner able to help them achieve their business initiatives."

Rochester Medical Implants, located in Rochester, Indiana, is a team of medical device manufacturing professionals bringing expertise to the entire product realization process. Whether working with customers to launch new technologies or improve existing devices, RMI innovates manufacturing processes that allow for improved quality and superior time to market. The company's core competencies include fully integrated services in CAD/CAM engineering, 5-axis CNC milling, turning and wire EDM, process development, material sourcing, laser marking, assembly and packaging.

ISO 13485:2003 applies to organizations involved with the product design, engineering and contract manufacturing services for medical device customers. The RMI facility, which includes a dedicated isolation room for the fabrication of implant grade PEEK-Optima products, can accommodate manufacturing, assembly and packaging of a wide variety of medical devices. The ISO certification process ensures ongoing compliance as companies are externally audited every twelve months.

RMI's quality policy says it all, "Critical products manufactured to the highest quality standards, first time, every time!"

Rochester Medical Implants serves as a subcontract manufacturer for large OEM suppliers of surgical orthopaedic products, as well as custom design houses working with leading orthopaedic surgical groups developing innovative implants and instruments. Many of our customers do not have in-house manufacturing capability and rely exclusively on RMI to prove out concepts, develop prototypes, provide assistance with design for manufacturability (DFM), and satisfy their production needs with short lead times. RMI is an SBA Certified HUBZone firm and maintains FDA registration for customer products.

Rochester Medical Implants is located in Rochester, Indiana. For more information visit http://www.rmi.us.com, email us at info@rmi.us.com, or call 574.223.8198.

This release was issued through eReleases(TM). For more information, visit http://www.ereleases.com.

Source: Rochester Medical Implants

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