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 5.2.4: Re-evaluate medical device risk analysis

What does 5.2.4 require?

The medical device risk analysis is re-evaluated when software requirements are established and updated as appropriate. Applies to classes A, B and C.

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