Victhom's Neurobionix business unit achieves ISO 13485:2003 certification
Victhom Human Bionics Inc., announced that its Neurobionix business unit has obtained ISO 13485:2003 certification for its Quality Management System to manufacture medical devices. This certification, an internationally recognized management system standard developed by the International Organization for Standardization (ISO), is a requirement for the manufacturing of a commercial medical device. Victhom's Neurobionix business unit manufacturing department produces medical devices such as implantable neuromodulation products.
"Achieving ISO 13485:2003 certification is an important corporate milestone for Neurobionix," said Mr. Nader Kameli, Chief Operating Officer of the Neurobionix business unit. "As all commercially available implantable devices have to be manufactured in compliance with ISO 13485 standards, this accomplishment is timely progress towards the commercialization of Neurostep (TM) in 2009," he continued. "Attaining ISO certification is another demonstration of our commitment to the quality of our products and processes. ISO certification will give our customers and business partners added confidence in our ability to develop technologically advanced products at quality standards generally associated with larger companies," he explained.
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