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 5.6.2: Verify software integration

What does 5.6.2 require?

The manufacturer verifies and records that the units have been combined into software items and into the software system as the integration plan requires, and keeps the evidence. This confirms that integration followed the plan, not that the outcome works as intended, and is usually done by inspection. Applies to classes B and C.

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