IEC/ISO 62304 is an international standard regarding Software Life Cycle Processes for Medical Devices. It is not as well-known as other medical device standards, but is now undergoing a significant revision. Software standards are taking on a more significant role these days. This is due to the number of devices that require software in order to operate correctly. Much like the medical device itself, software has a life cycle of its own, and in many cases, will be considered a stand-alone device (referred to as Software as a Medical Device, or SaMD).
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