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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.

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