In SoftwareCPR’s opinion, a somewhat unique, very well conceived, and well designed tool for the specialized craft of risk analysis as well as safety assurance cases. The tool is very configurable, allowing customized structures for your own methods. The ability to view data from an FMEA, FTA, or table view saves valuable time during creation...Read More
Latest News!
Updated Risk Management training course now available. Includes:
Coverage of ISO 14971, IEC 62304; amd1, and IEC/TR 80002-1.
Why FMEA is incomplete for medical device risk management.