Delcath’s Ireland location achieves ISO 13485 Certification
Wednesday, December 28, 2011
Delcath Systems has reported that the company’s Galway, Ireland location has achieved ISO 13485:2003 Certification–an internationally recognized quality standard designed to ensure that medical device manufacturers have the necessary comprehensive quality management systems in place to safely design, develop, manufacture and distribute medical devices in the European Union (EU). ISO 13485 Certification is a regulatory requirement of the EU’s Medical Device Directive, and represents an important step toward commercialization of the Delcath Hepatic CHEMOSATR Delivery System following its European CE Mark approval in April 2011.
“ISO 13485 Certification of our Galway facility confirms that our manufacturing and quality systems meet the high standards required of medical device companies selling into Europe,” said Eamonn P. Hobbs, CEO & president of Delcath Systems.