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 5.4.3: Develop detailed design for interfaces

What does 5.4.3 require?

A detailed design is developed and documented for the interfaces between each software unit and external components and between units, detailed enough to implement each unit and its interfaces correctly. Applies to class C.

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