As an expert in precision manufacturing, design and metal fabrication, MacKenzie Atlantic of Musquodoboit Harbour, Nova Scotia, was well positioned to answer the call for Canadian-made products to help in the fight against COVID-19. In only a few shorts weeks, the company expanded its operations to include the design and manufacture of face shields for healthcare workers. NRC IRAP played a role in facilitating this journey, providing guidance on safety and effectiveness testing, as well as the process of applying for a medical device establishment license (MDEL)—a necessary step for any company to sell or import any class of medical device in Canada. This support was provided through 2 NRC IRAP subject expert teams (SET)—the Regulatory SET and the Personal protective equipment SET—which were established to help Canadian businesses respond to COVID-19 in key priority areas. MacKenzie Atlantic received Health Canada approval and is now ready to deliver on supply contracts for up to 1.5 million face shields to Canadian health care workers.
"Thanks to the support of NRC IRAP, we were able to easily navigate the regulatory requirements needed to expand our operations and quickly produce Canadian-made solutions to protect front-line health care personnel working through the COVID-19 pandemic"