Quality Magazine

Objet Geometries Gains ISO 13485:2003 for Medical Devices Certification

November 4, 2010

REHOVOT, Israel-.Objet Geometries Ltd , the 3-D printing for rapid prototyping and additive manufacturing company, 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 3-D 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 3-D printing systems for the medical and dental arenas," says Gilad Gans, executive vice president. " This ISO 13485 medical certification validates our consistent obligation to high-quality 3-D printing systems and processes and provides independent confirmation that our Quality Management System is in full compliance with industry and regulatory standards."