GessNet Risk Management and Safety Case Tool

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 and reviews.  This tool even generates safety cases from your data. Definitely the new state of the art tool for these tasks.

It allows tabular data entry and views rather than strictly graphical formats which can be cumbersome on their own. bIt provides some powerful ways to utilize existing risk analysis information and more easily generating safety cases. It was developed to focus on medical device risk management per IEC 14971 and safety case generation where requested by the U.S. FDA.

For more information about FDA and international standards compliant risk management and safety case development or help tailoring your risk management process using the GessNet Tool, leave us a message below and one of our experts will contact you.

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

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15148 Springview St
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+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.