Risk Analysis/FMEA/FTA software tools

Risk/hazard analysis for medical devices and their software require extensive analysis, documentation, and maintenance of complex information. Creation and maintenance of extensive tables, fault tree, and HAZOP diagrams can seem overwhelming. For complex and high risk systems the information can be voluminous and software tools can be very productive.

Trace tools such as DOORS, CALIBER-RM, and others are commonly used to ensure that all risk control measures are specified and included in testing but they do not directly address the risk analysis process or the graphic diagrams where used.

Most tools that we are aware of which support the risk analysis process for medical devices are those originally developed for general reliability methods such as Fault Tree Analysis, and Failure Mode and Effects Analysis. Some of these have been extended to more explicitly support conformance with 14971 and medical devices in general.

Several of the tools that might be helpful in some situations include:

ASCE – graphical safety case tool
Relex FTA and FMEA tools
Dyadem products
CAFTA Computer Aided Fault Tree Analysis Tool
SoftRel software reliability prediction modeling tools being used by NASA

Doing a web search on FTA or FMEA software tools will identify many tools, however most of them are not directly tailored for risk management, just fault analysis.

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