Software Documentation (IEC 62304)

For devices incorporating software, ANVISA requires software lifecycle documentation based on IEC 62304 (Brazilian: ABNT NBR IEC 62304).

Key deliverables: software development plan, software requirements specification, software architecture, unit and integration testing, system testing, SOUP list (third-party libraries), and configuration management plan.

Software safety classification: Class A (no injury possible) / Class B (non-serious injury possible) / Class C (death or serious injury possible — most rigorous requirements).

---

Official sources

Verify all information against official ANVISA sources before making regulatory decisions.