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 5.5.2: Establish software unit verification process

What does 5.5.2 require?

The organization sets how each software unit will be verified, in strategy, method and procedure, and where testing is the method, it evaluates whether the test procedures are adequate. Applies to classes B and C.

Maintained by Gerard BlokdykControl text last updated

What else in your programme already covers this

This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

  • 6.2.8 6.2.8 Development and Review of Software for Custom Applications

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

Other controls in Clause 5: software development process – IEC 62304:2015 Medical Device Software Lifecycle Processes

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The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.