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 5.2.6: 5.2.6 Verify software requirements

The manufacturer verifies and documents that the software requirements implement the system requirements including those for risk control, do not contradict one another, avoid ambiguity, are stated so that test criteria can be established and tests performed, can be uniquely identified, and are traceable to system requirements or another source; no formal specification language is required. Applies to classes A, B and C.

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