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 5.3.3: 5.3.3 Specify functional and performance requirements of SOUP item

Where a software item is SOUP, the functional and performance requirements the SOUP item must meet for its intended use are specified. Applies to classes B and C.

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