CAE has received the ISO 13485:2016 certification for Medical Device and Quality Management Systems for its facilities in Montreal, Canada, and Sarasota, United States.
ISO 13485:2016 is an internationally recognized standard of quality and safety for medical device industry. The management system standard ensures that an organization meets the regulatory requirements specific to the design, manufacture and distribution of medical devices.
“As a high-technology company providing solutions for the civil aviation, defence and security and healthcare sectors, this certification is expanding the company’s potential and growth opportunities,” said Heidi Wood, Executive Vice President, Business Development & Growth Initiatives at CAE and Group President of CAE Healthcare.
In April 2020, CAE was awarded a Canadian government contract to develop and manufacture ventilators as part of a national emergency response to the pandemic. The CAE Air1 ventilator has since then been certified by the Public Health Agency of Canada.