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 5.1.3: 5.1.3 Software development plan reference to system design and development

The software development plan cites the system requirements as inputs to software development, and contains or points to procedures that coordinate software development and design validation with system development (system integration, verification and validation) as the quality management requirement demands. Where the software system is a standalone device made only of software, the two are treated as one. Applies to classes A, B and C.

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