Ximedica Achieves ISO 13485:2003 Certification for Medical Device Design and Manufacturing

October 23, 2006 —

Ximedica (www.ximedica.com), a wholly-owned subsidiary of Item Group specializing in the design, development, and supply of innovative new medical devices, announced today that it has achieved ISO 13485:2003 certification by auditor BSI Management Systems.

 

“The ISO certification process is a clear indication of Ximedica’s commitment to designing and manufacturing high quality products for the medical device market,” commented Robert E. Pelletier, CEO of Ximedica. “This accomplishment differentiates Ximedica from our competitors and allows us to provide our clients turn key solutions with quality results to help them achieve their business objectives.”

 

Ximedica is made up of a team of seasoned experts in design, mechanical engineering, electrical engineering, and manufacturing based in an 80,000 square foot facility in Providence, Rhode Island. Working with medical device companies to commercialize new technologies and improve human factors, with attention to ergonomics and user interface, for both providers and patients, Ximedica innovates new solutions that allow for improved care and better economics. The company’s core competencies include fully-integrated services in design, development and engineering as well as offshore sourcing, U.S. assembly, quality control and packaging.

 

-Ximedica selected BSI Management Systems, a leading quality management systems registrar known for holding its customers to the highest standard, as its notified body for ISO 13485:2003 certification.

 

The ISO 13485:2003 certificate scope includes product design, engineering and contract manufacturing services for medical device customers. The Ximedica facility will accommodate assembly and packaging of electro/mechanical capital medical devices as well as assembly and packaging of sterile and non-sterile medical disposables. The commitment to the ISO certification process ensures ongoing compliance and continuous improvement at Ximedica.

 

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