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MeVis Medical Solutions, Inc. has achieved certification to international quality system standard ISO 13485:2003 and the requirements of the CMDCAS for its Pewaukee, Wisconsin facility.

MeVis Medical Solutions, Inc. today announced that it has achieved certification to international quality system standard ISO 13485:2003 and the requirements of the Canadian Medical Devices Conformity Assessment System (CMDCAS) for its Pewaukee, Wisconsin facility.  The scope of the registration includes the design, development, manufacture, installation and service of medical imaging software systems and will enable MeVis to expand its product distribution into broader, international markets.

The ISO Certification signifies MeVis Medical Solutions' compliance with the quality management system standards developed by the International Organization for Standardization (ISO).  ISO is the International Organization for Standardization, a network of the national standards institutes of more than 150 countries.  ISO achieves international consensus on standards used to certify the safety and efficacy of products and processes including design and development, manufacturing, delivery and service.  The Canadian Medical Devices Conformity Assessment System (CMDCAS) requires that certain medical devices be designed and manufactured under a registered quality management system (QMS) that meets the criteria of these international standards.

"This is an important milestone in the short history of our new, US- based subsidiary," said Thomas Tynes, President & CEO of MeVis Medical Solutions, Inc.  "Certification to these international standards will help support the expansion of our product distribution into new markets outside of the US.  It also demonstrates to our customers that we have the systems in place to ensure we consistently deliver products and services which meet the highest standards for clinical performance, safety and reliability."

MeVis' quality system certification also paves the way for the distribution of a number of new products that the company is planning to introduce over the next several months. Tynes added:  "Our ISO certification will help accelerate the market introduction and ensure broader distribution of several exciting new products – both here in the US and abroad."