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 9.1: 9.1 Prepare problem reports

Every problem found in the software product gets a problem report. The report states how critical the problem is (its effect on performance, safety or security) and gives other details that help resolve it, such as which devices and supported accessories are affected, along with its type (corrective, preventive or adaptive) and its scope. Problems can surface before or after release and from inside or outside the organization. Applies to classes A, B and C.

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