All posts by Mark Vanderveken

Mark Vanderveken is an Associate at Fasken in Toronto, Ontario

Canada to Toughen Standards for Medical-Device Safety and Cybersecurity

Health Canada recently released two significant forward-looking documents on the regulation of medical devices: Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality (1) (Action Plan); and Draft Guidance Document: Pre-market Requirements for Medical Device Cybersecurity (2)(Cybersecurity Guidance) These publications are expected to inform changes to Canada’s medical device regulatory regime to expand … Continue reading Canada to Toughen Standards for Medical-Device Safety and Cybersecurity