SAN DIEGO, March 14, 2013 /PRNewswire/ -- Cardium Therapeutics (NYSE MKT: CXM) today announced that it has received ISO 13485:2003 certification for its Excellagen ® advanced wound care product by BSI, one of the world's leading certification bodies. The ISO 13485:2003 certification is a stand-alone standard developed by the International Organization for Standardization that provides harmonized quality management systems requirements for manufacturers of medical devices. In their ISO report, BSI's auditors noted that "Cardium's quality management system has been effectively implemented, addresses the proposed scope of product registration and is in accordance with the company objectives and applicable requirements of the management standards." Cardium's compliance with ISO 13485 represents an important next step forward to compliance with European regulatory requirements.
"This ISO certification represents a major achievement and milestone for Cardium and moves us forward in our CE Mark Certification application for authorization to market and sell Excellagen in the European Union, which currently consists of 27 member countries," stated Christopher J. Reinhard, Chairman and CEO of Cardium Therapeutics.
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