In early 2019 Health Canada released more specifics of their Action Plan on Medical Devices. The Action Plan is intended to reinforce Health Canada’s commitment to ensuring that Canadians have access to safe and effective medical devices based upon the most up to date information. It has a three-prong strategy involving: i) improve regulatory rigor […]
Posts by Deborah Pinchev
Are you a manufacturer of a medical device that is in the early stages of development interested in gathering clinical data in the United States? Your device design will likely change, but the information needed is best gathered through clinical experience as opposed to non-clinical testing.
Cyber attacks are not just a potential threat, they are a reality. It seems that every other week a cybersecurity issue is making headlines globally. We live in an ultra-connected world where medical devices are a big part of what is connected.