The accreditation ensures that the Delcath’s location is safe to design, develop, manufacture and distribute medical devices in the European Union (EU).
Delcath Systems CEO & president Eamonn Hobbs said ISO 13485 certification of their Galway facility confirms that their manufacturing and quality systems meet the high standards required of medical device companies selling into Europe.
"This achievement represents one more important milestone toward commercialization of Chemosat delivery system in the EU, and we are looking forward to a successful initial launch of the product early next year," Hobbs said.
