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 5.6.6: Conduct regression tests

What does 5.6.6 require?

Whenever software items are integrated, suitable regression tests are run to show that the software already integrated has not acquired new defects. Applies to classes B and C.

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