OCULUS Surgical, Inc., the sole source for the OCULUS SDI®/BIOM® family of products in the U.S., today announced it has received ISO 13485:2003 certification. This certification is an internationally recognized system standard developed by the International Organization for Standardization (ISO). This certification confirms the company’s Quality Management System and the company’s processes and procedures are controlled, documented, and compliant with stringent requirements.
“The ISO certification is a significant accomplishment and an important milestone for OCULUS Surgical, Inc.” said Ron Gilliland, President and CEO. “Having obtained ISO 13485 certification within our first year of operation is proof of our commitment to quality, and to our customers.”
Companies receiving the ISO 13485 certification must demonstrate an ability to provide medical devices, services, and support that consistently meet customer and regulatory requirements. “Achievement of ISO certification offers our customers an additional level of confidence in the quality and reliability of OCULUS Surgical’s products and services,” said Gilliland.
OCULUS Surgical, Inc., a wholly owned subsidiary of OCULUS Optikgeräte GmbH, is the exclusive source for the SDI®/BIOM® non-contact wide angle viewing system in the U.S. OCULUS Surgical, Inc. builds upon the strong heritage of its parent company by providing ophthalmic surgeons with innovative, high quality ophthalmic products and the highest level of customer support.
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