IEC 62304:2015 Medical Device Software Lifecycle Processes
Clause 6: software maintenance process – IEC 62304:2015 Medical Device Software Lifecycle Processes

IEC 62304:2015 Medical Device Software Lifecycle Processes 6.2.2: 6.2.2 Use software problem resolution process

The software problem resolution process of clause 9 is used to address problem reports, which may show that a system or item was not in the correct safety class and suggest a change of class, to be made known and documented. Applies to classes A, B and C.

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