Edge Orthopaedics Now ISO Certified

Boonton, N.J.-based Edge Orthopaedics has achieved ISO 13485:2003 certification for its quality management system from the certification body British Standards Institute. ISO 13485:2003 defines the standards for a quality management system for organizations providing medical devices and related services that consistently meet customer and regulatory requirements.

“Achieving this certification has been a priority since the company was founded in mid-2012. This is an amazing accomplishment for a company of our size,” said Jan Triani, director of regulatory affairs and quality assurance for Edge Orthopaedics. “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.”

Edge earned its first U.S. Food and Drug Administration 510(k) clearance in February for its Bite compression screw for foot and ankle procedures. The company develops solutions for the foot/ankle and extremities markets.