Objet Geometries Ltd., announced that it has achieved the ISO13485:2003 certification for medical devices. ISO 13485 is an international standard that specifies requirements for a quality management system for the design and development, production, installation and servicing of medical devices. This certification indicates that Objet’s 3D printers and related services meet the regulatory requirements applicable to medical devices.
Said Gilad Gans, executive vice president, Objet Geometries, “We are committed to the medical industry and to meeting our medical and dental customers’ expectations while adhering to strict regulatory compliance regulations. This ISO 13485 medical certification validates our consistent obligation to high-quality 3D printing systems and processes and provides independent confirmation that our Quality Management System (QMS) is in full compliance with industry and regulatory standards.”
Avi Cohen, head of Medical Solutions, Objet Geometries, added: “ISO13485 has become the standard against which medical device suppliers are measured to drive quality within the medical and dental market. The addition of ISO13485 complements our existing ISO standards.”
Objet Geometries Ltd.