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 5.2.3: Include risk control measures in software requirements

What does 5.2.3 require?

Where appropriate, the software requirements include the risk control measures that software provides against hardware failures and possible software defects, accepting that these may appear and change as design and risk control progress. Applies to classes B and C.

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