ISO 13485 certification will enhance product sales in Europe and Canada
October 18, 2007
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 TÜV SÜD America, Inc., a subsidiary of TÜV SÜD AG, the largest German TÜV with 2006 revenues of EUR 1.17 billion. They are a world leader in ISO medical device quality system certifications.
Verax Biomedical’s primary product is the Platelet PGD Test, an easy-to-use, disposable device designed to detect the presence of a broad range of bacterial contaminants in platelets at a later phase in platelet unit life than current culture methods. Bacterial contamination in platelets and red blood cells represents the single greatest risk for lethal infections in transfusion medicine today. An estimated 10 million platelet units are transfused each year into patients in North America, Europe and Asia, and experts estimate that as many as one in every 2,000 units is contaminated with bacteria.
The Verax PGD Test is based on Verax Biomedical’s proprietary Pan Genera® Detection technology, which targets common antigens found on the surface of all species of bacteria known to be pathogenic to humans.
For additional information, visit www.veraxbiomedical.com. Verax is located at 377 Plantation Street, Worcester, MA 01608. Tel.: 508-755-7029.
About Verax Biomedical, Inc.
Based in Worcester, Mass., Verax Biomedical is a leader in the development of rapid tests designed to detect a broad range of bacterial contaminants based upon its proprietary Pan Genera Detection (PGD) technology. The first target application for its technology is to test for the presence of bacterial contaminants in the blood supply. Bacterial contaminants in platelets and red blood cells represent the greatest lethal infectious risks in transfusion medicine today, and no rapid, simple methods are presently available to effectively address this threat. Each year an estimated 17 million patients receive more than 60 million units of these individual blood components in North America, Europe and Asia.
SOURCE Verax Biomedical Inc.
The Company's first product is the Platelet PGD Test – a rapid test for the detection of bacterial contamination in platelets.