ZEVEX International (NASDAQ: ZVXI), today announced that, following an intensive review by TUV America, ZEVEX has met the rigorous requirements for certification to ISO 9001:2000 and ISO 13485:2003. In addition, the company demonstrated during this review that its products conform to the European Union's Medical Device Directive (MDD) and the Canadian Medical Device Regulations (CMDR). The ISO certification is a globally recognized quality accreditation system. Some of the new ISO requirements relate to design controls, process controls (including environmental controls), special processes, traceability, record retention, and regulatory actions, which are critical for the medical device industry. The new certifications allow ZEVEX's medical devices to be freely distributed in the European Union and Canada, without the need for additional product inspections. David McNally, president and CEO, ZEVEX, said, "These certifications confirm our commitment to product quality and customer satisfaction. I am very proud of the team effort that was put forth by our employees to obtain these certifications. Employees from Quality Assurance, Operations, Research and Development, Customer Service and Marketing all played key roles in reaching this goal. The auditors focused on quality management systems, production processes and controls, design controls, customer-related processes, and customer satisfaction measurement. The professionalism and knowledge of the entire ZEVEX team in these areas directly contributed to these certifications." About ZEVEX ZEVEX International Inc. (www.zevex.com), founded in 1986, is a diversified medical device company committed to creating products that transform life with patented and proprietary medical device technologies -- from sensors and surgical tools to medical electronic systems. For more information concerning ZEVEX and its products, please visit the ZEVEX Web site at the following link: www.zevex.com.
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