PERTH, WA, November 2020
AIRO achieves world’s highest quality standard
It’s only three letters and five numbers, but to the dedicated team at the Australian Institute of Robotic Orthopaedics (AIRO), it means the world.
It’s called the ISO 13485 certification and it’s decided by the British Standards Institution (BSI Group), the world’s premier accreditor of quality management systems (QMS). After an extensive auditing process, AIRO has been awarded this endorsement for the quality of its medical device systems.
This significant global standard covers all aspects of AIRO’s technology development, from the initial design stage, through to development, production, installation, delivery and ongoing maintenance and customer service.
“Implementing a quality management system is a crucial part of professional compliance in our field,” said AIRO’s Managing Director and CEO Associate Professor Brett Robertson, “The development and registration of medical devices in the major worldwide markets is necessarily regulated to an extremely high degree and we’re committed to meeting those standards in everything we do.” According to the British Standards Institute, companies with ISO 13485 certification have proven themselves to be committed to the highest levels of quality control to both customers and regulators.
AIRO now holds Certificate No. MD 726905, and operates a quality control system which complies with the requirements of ISO 13485:2016 and EN ISO 13485:2016 for the design and development of laser treatment system for arthrotomy and joint arthroplasty.
“We like to think that this ISO certification was made all the more achievable by the significant investment we’ve made in developing our own quality systems in-house,” said AIRO Director and Chairman Professor Michael Henderson, “Not to mention our amazing people. You can’t reach such high standards without an incredibly dedicated and diligent team. The board of AIRO are extremely proud of the team’s efforts and achievement of this global standard.”