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FDA | MDR

Software as a Medical Device

Advancements in technology over the past several decades have naturally led to advancements in healthcare. Software as a medical device (SaMD) is particularly poised for growth with one of the latest advancements: the Internet of Things (IoT). Because of this and other factors, the SaMD market is expected to grow at a compound annual growth rate of 21.9 percent from 2020 to 2027, bringing the value to just over $86 million. This growth represents potential lifesaving innovation for providers and patients. However, for manufacturers, especially those that are new to SaMD, it represents new complications in regulatory affairs and risk management.
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