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 5.7.2: 5.7.2 Use software problem resolution process

Any anomaly found in software system testing is fed into the software problem resolution process. Applies to classes A, B and C.

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