PERTH, WA, November 2021
AIRO again recognised by Global Standards Organisation
Anywhere in the world you go, manufacturers of medical devices agree there is one measure of quality they aspire to above all others: ISO 13485.
Which is why we’re proud to announce that the Australian Institute of Robotic Orthopaedics (AIRO) had its ISO 13485 certification reassessed by the British Standards Institution (BSI), the world’s leading accreditor of quality management systems, and has again been recognised internationally for the quality of its medical device manufacturing.According to the BSI, companies with ISO 13485 certification have proven themselves to be committed to the highest levels of quality control to both customers and regulators.
“Progressing and maintaining a quality management system (QMS) is a crucial part of professional compliance in our field,” said AIRO Chief Technology Officer Mr Richard Chipper, “The development and registration of medical devices in the major worldwide markets is rightfully regulated to a high degree and we’re committed to meeting those standards in everything we do.”
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 control system which complies with the requirements of ISO 13485:2016 and EN ISO 13485:2016.
“For AIRO, maintaining this certification isn’t just a company protocol.” said Managing Director and CEO Associate Professor Brett Robertson, “It reflects our entire team’s dedication to excellence. Our people are all world-class and we’re extremely proud of them.”