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).
Verify all information against official ANVISA sources before making regulatory decisions.
Software documentation is required for all devices that incorporate software, whether embedded firmware or standalone software applications. The extent of documentation required depends on the software safety classification: Class A software (minimal risk) requires basic documentation; Class B requires standard IEC 62304 documentation; Class C requires the most comprehensive documentation including formal verification and validation protocols.