CAE receives ISO 13485:2016 certification for medical device design, manufacturing and distribution

CAE announces today that it has received the ISO 13485:2016 certification for Medical Device and Quality Management Systems for its facilities in Montreal (Canada) and Sarasota (United-States).

“We are extremely proud of the work of our passionate employees who completed the ISO 13485-2016 certification process, which recognizes that CAE meets all the requirements to design and manufacture medical devices, said Pascal Grenier, Senior Vice President, Global Operations, Technologies & Innovation. This project is the perfect demonstration of CAE’s expertise, agility, speed and a testament to our commitment to safety and quality.”

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. “We continuously find innovative ways to provide solutions to make the world a safer place. CAE has been an innovation powerhouse for more than 70 years, with world-class engineering, intellectual property, supply chain and manufacturing capabilities. We are proud to have the ability to apply our competencies in the medical device sector.”

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.