Objet Geometries Gains ISO 13485:2003

Objet Geometries Ltd., the innovation leader of 3D printing for rapid prototyping and additive manufacturing, announced today that it 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. This international standard confirms Objet’s ability to provide the medical industry with 3D printers and related services that meet the regulatory requirements applicable to medical devices.

“We are very pleased to achieve this ISO certification, which is a further reinforcement of the quality of our 3D printing systems for the medical and dental arenas,” says Gilad Gans, Executive Vice President at Objet Geometries. “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,” added Gans.

Avi Cohen, Head of Medical Solutions at 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. The medical and dental industry is a major strategic focus for Objet Geometries and this certification represents an important milestone, further supporting our vision to be recognized for 3D printing solutions for the ongoing manufacturing of commercial medical and dental devices.”