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 5.1.7: Software risk management planning

What does 5.1.7 require?

The plan contains, or points to, a plan covering the clause 7 software risk management activities and tasks, managing SOUP-related risk included. Applies to classes A, B and C.

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