On April 19, 2021, FDA issued a final rule that amends its device classification regulations to exclude from regulation as a medical device certain types of software functions for certain products.

Already under the current MDD regime, medical devices, such as stand-alone MDSW, are classified according to their intended purpose and their inherent risks, and are divided into the following four ...

In today's digital landscape, organizations face an unprecedented challenge: managing and protecting ever-growing volumes of data spread across multiple environments. As someone deeply involved in ...