Software as a Medical Device (SaMD) is defined by regulatory bodies like the FDA and IMDRF as "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device."

Software as a medical device distinguishes itself from conventional medical device software, which is associated with proprietary hardware such as MRI machines using algorithms, data analysis, & artificial intelligence to deliver clinical results like disease diagnosis or chronic condition tracking through sensor readings and user input. Software as a medical device is independent of proprietary hardware. The global SaMD market is projected to reach $5.0 billion by 2033, growing at a compound annual growth rate (CAGR) of 13.6% from $1.4 billion in 2023. This signifies that it is scalable and deployable on platforms like mobile apps, cloud infrastructures, and AI diagnostic platforms.

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