FDA details regulatory framework for AI/ML-Based Software as a Medical Device

In April 2019, the US Food and Drug Administration (FDA) published a discussion paper and request for feedback regarding their proposed regulatory framework for Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD). Following feedback from the industry, the FDA has now published a five part action plan. Read more “FDA details regulatory framework for AI/ML-Based Software as a Medical Device”

Canada implements new regulations to strengthen post-market surveillance and risk management of medical devices

Heath Canada is making changes to its Medical Devices Regulations with the aim of improving their ability to identify, assess and manage new risks for medical devices used in Canada. Read more “Canada implements new regulations to strengthen post-market surveillance and risk management of medical devices”