[October 17, 2008] Cardiac Dimensions Gets ISO Certification Tweet (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 [email protected])) ((Distributed on behalf of 10Meters via M2 Communications Ltd - http://www.m2.com)) ((10Meters - http://www.10meters.com)) Copyright ? 2008 Wireless News [ Back To TMCnet.com's Homepage ]