IEC 62304:2015 Medical Device Software Lifecycle Processes
Clause 5: software development process – IEC 62304:2015 Medical Device Software Lifecycle Processes

IEC 62304:2015 Medical Device Software Lifecycle Processes 5.3.4: Specify system hardware and software required by SOUP item

What does 5.3.4 require?

Where a software item is SOUP, the system hardware and software the SOUP item needs to operate properly (processor type and speed, memory, system software, communication and display software) are specified. Applies to classes B and C.

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