PERTH, WA, September 2022
AIRO Maintains Global Standard in Medical Devices
We’re proud to announce that the Australian Institute of Robotic Orthopaedics (AIRO) has again been recognised globally for the quality of its medical device manufacturing following a successful audit of its ISO 13485 certification by the British Standards Institution (BSI).
ISO 13485 is the international standard for medical device quality management systems (QMS). Companies with ISO 13485 certification have proven themselves to be committed to the highest levels of quality control to both customers and regulators.
“Our quality management system is a crucial part of the development process,” said AIRO Chief Technology Officer Mr Richard Chipper, “The technical rigour required to comply with this global standard improves and guides our decision making. It is now embedded into the fabric of our organisation and has become second nature.”
AIRO was first awarded Certificate No. MD 726905 in November 2020 for the design and development of a laser treatment system for arthrotomy (the surgical exploration of a joint) and joint arthroplasty (the surgical replacement of a joint), and continues to operate a quality management system that meets the requirements of ISO 13485:2016 and EN ISO 13485:2016.
“The continued maintenance of our global certification reflects our entire team’s dedication to excellence,” said Managing Director and CEO Associate Professor Brett Robertson, “I am extremely proud of their efforts.”