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Edge Orthopaedics issued ISO 13485 Certification
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Edge Orthopaedics recently announced it has received ISO 13485:2003 certification for its quality management system.
The ISO 13485:2003 defines quality management system standards for organizations that provide medical devices and related services that consistently meet customer and regulatory requirements, according to a company press release. The certification comes from the British Standards Institute, a leading certification body.
“This is an amazing accomplishment for a company of our size,” Jan Triani, regulatory affairs and quality assurance director for Edge Orthopaedics, said in the release. “As a new medical device manufacturer, our goal was not only to comply with all FDA guidance and regulations, but also to go a step further and become ISO-certified. Our decision was fueled by the team’s passion to provide the very best products to our customers.”