Artes Medical Obtains ISO 13485:2003 Quality System Certification

SAN DIEGO–(BUSINESS WIRE)–Jan. 5, 2006–Artes Medical, a fully-integrated medical technology company focused on the development, manufacture and commercialization of a new category of permanent injectable aesthetic products, today announced it has received a quality system certificate demonstrating compliance with ISO 13485:2003, the internationally recognized quality system standard for medical device manufacturers. Artes Medical joins the ranks of internationally renowned medical device manufacturers who have obtained ISO 13485:2003 quality system certificates. ISO 13485:2003 specifies quality management system requirements for an organization to demonstrate its ability to consistently provide products and services at the highest level of quality. The ISO 13485:2003 certificate is the first step towards demonstrating compliance with appropriate medical device regulatory and statutory requirements for CE-marking in the European Union and for Canadian approval. Developed by the International Organization for Standardization, ISO 13485:2003 is a stand-alone medical device quality system standard especially intended for the medical device industry focusing on regulatory quality system requirements.