AcelRx Pharmaceuticals Receives International Standards Organization Certification Of Its Quality Management System

AcelRx Pharmaceuticals, Inc.

, a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain today announced that it has been granted International Standards Organization (ISO) 13485:2003 certification of its quality management system, an internationally recognized quality standard for medical devices issued by the British Standards Institution (BSI). ISO 13485:2003 certification recognizes that consistent quality policies and procedures are in place at AcelRx for the development, design and manufacturing of medical devices. The certification indicates that AcelRx has successfully implemented a quality system that conforms to ISO 13485 standards for medical devices. Certification to this standard is one of the key regulatory requirements for a CE Mark in the European Union as well as requirements in other international markets. The certification applies to the Redwood City, CA location which designs, manufactures and distributes finished medical devices. "The ISO certification is an important milestone for AcelRx as we work together with Gruenenthal towards bringing Zalviso to the European market," stated Richard King, president and CEO of AcelRx. "The certification confirms that our Quality System meets the highest standards."