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 5.2.5: Update system requirements

What does 5.2.5 require?

Following the analysis of software requirements, existing requirements, system requirements among them, are reassessed and revised where needed. Applies to classes A, B and C.

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