AI in clinical medicine and healthcare

“Software as a device is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”

 As defined by International Medical Device Regulators Forum (IMDRF)

We discussed the past, as well as some aspects of the current regulatory framework for medical devices over the past few weeks. We will cover additional aspects this week, as well as next week (part IV).

As a result of public discussions, this discussion paper led to the AI/ML Software as a Medical Device Action Plan that will be a…