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IEC 62304 medical-device software documentation

IEC 62304, Medical device software — Software life cycle processes, governs how medical-device software is developed and documented. Much of what an IEC 62304 submission needs is exactly what Understand produces: enforced coding standards, design documentation derived from the code, and per-rule evidence. As with ISO 26262 and DO-178C, Understand supports the program — it is not a single "IEC 62304 mode."

Certification & qualification claims live on one page

Any statement about Understand's certified status or how tool use maps to your device's safety class is answered authoritatively — with the right caveats — in Is Understand certified?. Confirm the scope for your release with support@scitools.com.

1. Enforce the coding standards

Medical software programs commonly mandate MISRA (C / C++) and SEI CERT (C / C++) for both safety and security. Map your obligation to a configuration in Which standard should I check against?, then run and triage as in Run your first check. Security requirements — increasingly part of medical-device submissions — are covered in Check code for security vulnerabilities.

2. Produce the design documentation

IEC 62304 expects software architecture and detailed design documentation. Generate it from the code so it stays accurate — control-flow diagrams, call trees, UML, dependency graphs, and interactive reports — see Generate design documentation from your code. Documentation that regenerates on demand is far easier to keep in sync with a changing codebase than hand-drawn diagrams.

3. Evidence conformance

When it's time to demonstrate the coding standard was met, produce a compliance report — the per-rule Compliant / Not Compliant / needs- manual-review artifact, paired with your documented deviations.

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