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General overview of regulatory requirements for software as a medical device

The regulation of software as a medical device is required to ensure that software used for medical reasons produces accurate, safe, and effective outcomes.

A software application that is meant to be used for the diagnosis, treatment, or monitoring of diseases or impairments is considered a medical device. The FDA based its policies on the specific function of the software. This means that different regulations may apply depending on the aim of the software.

Read More on Medical Device Network