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 9.7: 9.7 Verify software problem resolution

Each resolution is verified to establish whether the problem is fixed and the report closed, whether adverse trends have turned around, whether the change requests were carried out in the right products and activities, and whether the fix has created new problems. Applies to classes A, B and C.

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