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 5.3.1: 5.3.1 Transform software requirements into an architecture

The software requirements are turned into a documented architecture that sets out how the software is structured and names its software items. Applies to classes B and C.

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