IEC 62304:2015 Medical Device Software Lifecycle Processes
Clause 9: software problem resolution process – IEC 62304:2015 Medical Device Software Lifecycle Processes

IEC 62304:2015 Medical Device Software Lifecycle Processes 9.3: 9.3 Advise relevant parties

Where appropriate, the relevant parties are told that the problem exists; the manufacturer decides in each case who counts as relevant. Applies to classes A, B and C.

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