Creating a Software Assembly Line

Abstract

This thesis describes a technical solution that improved the software development efforts needed to verify and validate a medical device, herein referred to as the “medical device.” The medical device had many software and hardware configurations that had to be developed, integrated, managed, and tested. There were a number of problems with the manual processes that were being used to verify and validate the product, so this project developed a system called the “Software Assembly Line” to continuously build software and automatically test it on multiple hardware configurations. As a result, software quality and predictability were improved, and the number of cycles required for formal verification and validation was reduced. The final project recommendation was to validate the Software Assembly Line according to 21CFR820.75, Process Validation