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 5.1.8: 5.1.8 Documentation planning

The plan includes or references, for each document or document type to be produced, its title, name or naming convention, purpose, intended audience, and the procedures and responsibilities for its development, review, approval and modification. Applies to classes A, B and C.

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