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Cardiac Dimensions Gets ISO Certification
(Wireless News Via Acquire Media NewsEdge)
Cardiac Dimensions announced that it has received ISO 13485:2003
certification from Kema Quality B.V., a European Union Notified Body
from the Netherlands.
ISO 13485:2003 is an international standard for quality management
systems, specifically for medical devices. The certification is an
important measure of the company's quality capabilities and is a key
requirement in obtaining the CE Mark.
Paul Cornelison, Vice President of Regulatory Affairs & Quality
Assurance, said, "This certification validates the company's efforts to
establish, document and maintain an effective quality management
system. I am pleased that the entire company has been committed to
achieving and maintaining this status."
"The ISO certification has been a key objective of ours," said Rick
Stewart, Cardiac Dimension's President and CEO. "It represents a
validation of our high standards in terms of product design along with
our manufacturing and distribution processes. We are also working
toward gaining the CE Mark for our CARILLON system; this ISO
certification provides a foundation to meet the specific quality
requirements for the countries that accept CE Marking."
Cardiac Dimensions, based in Kirkland, Washington, develops and
manufactures devices designed for treating heart failure and related
conditions.
((Comments on this story may be sent to newsdesk@closeupmedia.com))
((Distributed on behalf of 10Meters via M2 Communications Ltd -
http://www.m2.com))
((10Meters - http://www.10meters.com))
Copyright ? 2008 Wireless News
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