Zevex (NASDAQ:ZVXI)
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From Jun 2019 to Jun 2024
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.