Digital health solutions and SaMD; Pharma’s five steps for success

For those looking to build digital health solutions, Software as a Medical Device (SaMD) is now an essential distinction to be aware of. While all products classified as SaMD will be digital health solutions, not all digital health solutions are classified as SaMD, so it’s important to be clear on where the distinction lies. Put simply, SaMD is (as per the International Medical Device Regulators Forum), “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” Software does not however meet the definition of SaMD if its intended use is to drive a hardware medical device or simply fetch data.

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