Delcath Systems, a provider in oncology, has achieved ISO 13485:2003 Certification, to ensure that medical device manufacturers have the necessary comprehensive 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 a step toward attaining European CE mark approval for the company’s proprietary Hepatic ChemoSAT Delivery System.
Hepatic ChemoSAT Delivery System will fulfill an unmet clinical need for many liver cancer patients in EU region, by the percutaneous intra-arterial administration of a chemotherapeutic agent (melphalan hydrochloride) to the liver.
Delcath Systems CEO and president Eamonn Hobbs said ISO 13485 Certification confirms that their manufacturing and quality systems meet the high standards required of medical device companies selling into Europe, and they are pleased to have achieved this important milestone toward the receipt of CE mark approval.
"Our technical file for CE Mark is pending, and we continue to expect CE Mark approval for our product in mid-2011," Hobbs said.