Tool Validation Kit

Copyright 2018 The MathWorks, Inc.

In order to comply with the US Food and Drug Administration’s Quality System Regulations, any software tool that is used as part of a medical device development process must be validated as fit for its intended use. Such validation of MATLAB, which requires documentation of context of use, risks of failure, and mitigation strategies, is outside the scope of this document. However, a very common risk mitigation strategy for commercial off-the-shelf software is to run a set of validation tests to confirm correct results on the end user’s computer. This app provides such a set of tests from The MathWorks. The resulting test report may be used as evidence for a MATLAB software validation plan. In addition, documentation is provided to extend these tests for any additional features that are considered high risk for the end user’s particular context of use.

A test suite is provided for many commonly-used features of MATLAB and the Signal Processing Toolbox. Major add-on features, such as the Image Processing Toolbox, warrant additional test cases.