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 9.8: 9.8 Test documentation contents

Whenever software items or systems are tested, retested or regression tested following a change, the test records capture the outcome, any anomalies found, which software version was tested, the hardware and software configurations used, the test tools, the date, and who performed the test. Applies to classes A, B and C.

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