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.

62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

Need info?  Email us at training@softwarecpr.com

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