ISO 13485 Certification Will Enhance Product Sales in Europe and Canada
WORCESTER, Mass., Oct. 18 /PRNewswire/ -- Verax Biomedical Inc., a leading developer of rapid tests for detecting bacterial contaminants in blood cells and tissue, has received ISO 13485:2003 certification. ISO is a quality management standard developed by the International Organization for Standardization that represents independent confirmation that the company has implemented an effective quality management system that addresses all areas of its operations including the design, development and manufacturing of its products. The Company's certification comes on the heels of 510(k) clearance last month for its Platelet PGD Test System from the U.S. Food and Drug Administration (FDA).
ISO certification clears the way for the marketing of Verax manufactured products in the world market. Having ISO certification is not simply an advantage, but is often stipulated by countries such as Canada and in Europe. "We are very pleased to hear the news. ISO certification is a key step in the maturation of the company from R & D to commercialization and routine manufacturing of the Platelet PGD test," said Jim Lousararian, chief executive officer of Verax Biomedical. "ISO certification is vital to marketing our products in Europe and throughout the global marketplace."
ISO 13485:2003 is a family of international standards covering various requirements for implementing a quality management system, and provides a framework for continuous improvement. Scott McKenzie, Senior Vice President of Operations of Verax Biomedical, led the internal ISO certification quality team. McKenzie said, "We began the formal ISO process in January and ended with a final inspection in August. The real credit goes to our team that set the table prior to January with quality systems already in place so we could quickly receive certification."
Verax was evaluated by TUV SUD America, Inc., a subsidiary of
|SOURCE Verax Biomedical Inc.|
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