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 5.4.2: 5.4.2 Develop detailed design for each software unit

A detailed design is developed and documented for each software unit with enough detail to allow its correct implementation. Applies to class C.

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