Medical devices and other regulated safety-critical industries face a unique set of challenges and strict requirements for verifying and validating their products and quality systems. Testing and verifying products as well as creating the necessary documentation is a tedious and time-consuming process. It also traditionally occurs after the completion of algorithm development when the discovery of late stage bugs can derail a project or add costly delays. Additionally, regulatory bodies require validation of the software development tools used in the design and manufacturing process. The design tools must be validated by the medical device manufacturer or drug developer—not the tool vendor—per the manufacturer’s context of use for these tools. 

In this presentation, you will see how both the algorithm verification and tool validation processes can be automated using the MATLAB^® Unit Test Framework and the Tool Validation Kit for MATLAB.