Objet Geometries, a provider of 3D printing for rapid prototyping and additive manufacturing, has achieved the ISO13485:2003 certification for medical devices.
ISO 13485 specifies requirements for a comprehensive quality management system for the design and development, production, installation and servicing of medical devices and confirms Objet’s ability to provide the medical industry with 3D printers and related services that meet the regulatory requirements applicable to medical devices.
Objet Geometries executive vice president Gilad Gans said that they are very pleased to achieve this ISO certification, which is a further reinforcement of the quality of their 3D printing systems for the medical and dental arenas.
“We are very 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,” Gans said.