EDGE Orthopaedics has obtained an ISO 13485:2003 certification for its quality management system from the British Standards Institute (BSI).
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.
EDGE Orthopaedics regulatory affairs and quality assurance director Jan Triani said 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.
"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," Triani added.
"Our decision was fueled by the team’s passion to provide the very best products to our customers."
ISO 13485:2003 is an international standard, globally recognized for establishing quality management systems that consistently meet customer and regulatory requirements for safe and effective medical devices.
ISO 13485 is based on quality management principles that have been proven to enhance organization performance. These principals relate to customer focus, management, internal processes and external relationships.