The ISO 14971 Risk Management Tool

Quickly reach compliance with ISO 14971 - Application of risk management to medical devices?

Do risk analysis your way and not the way a tool prescribes it?

Automatically ensure that your mitigations are implemented?

Use pre-configured Potential Hazards from ISO 14971?

Monitor the effect of your mitigations in a pre- and post-mitigation Risk Summary?

Be warned if you have incomplete risk coverage or unmitigated risks?

Spend less time on maintaining documents?

By easily tracing ISO 14971 risk controls / mitigations to your design inputs

By automating checks for not implemented mitigations

By checking the completeness of your risk management in seconds

By re-using mitigations to save time and ensure consistency

By using configurable (preliminary) hazard analysis (PHA) and FMEA in a single tool

By creating and updating your risk management files at the press of a button