Apply our highly configurable Preliminary Hazard Analysis and FMEA components. Parameter naming, ranges, risk calculations, and thresholds are configured according to your needs.

Automatic checks ensure that all risks are mitigated and that all risk control measures are implemented and verified.

Connect the risk evaluations to your IEC 62304 Software Items, Software Units, and SOUPs to drive their Software Safety Classification.

Correct classification throughout the architecture is ensured by quality checks.