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 5.1.1: 5.1.1 Software development plan

One or more software development plans are set up to cover the development activities, suited to the scope, size and safety class of the software system. The plan fully defines, or refers to, the life cycle model used for development and addresses: the processes to be followed; the deliverables of activities and tasks, documentation included; traceability that links system requirements, software requirements, system tests and the software-implemented risk control measures; managing configuration and change, covering configuration items that are SOUP as well as development support tools; and problem resolution at every life cycle stage. The model may vary by item class and may be iterative, and the plan may sit within the overall system plan. Applies to classes A, 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.

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

Query this from an agent

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