GG VS Q2 2026 - Software risk management under ISO 14971

For software teams, the mapping from code-level failures to patient harm passes through layers of abstraction that hardware risk analysis doesn't face. A race condition, a rounding error, a communication timeout: these aren't obvious hazards, and documenting the causal chain requires a different analytical approach. This session makes ISO 14971 practical for software teams. It covers how to link software hazards to system-level risks, how to integrate risk items with design controls so risk evolves with the software instead of becoming a static document, and how to manage third-party software (SOUP) risk without over-engineering it. The most common audit gap in software risk files is not missing risk items. It is a risk file that was accurate at v1.0 and never updated as the software evolved. This session shows how to make risk management a living part of development, not a QA artifact that drifts between submissions.