Objet Geometries Gains ISO 13485:2003 for Medical Devices Certification
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."
"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."
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