The topic of sofware validation for medical devices is not an easy step in setting up the QMS, there seems to be comparably little actual information available on how to go about things the “right” way. There’s some good lessons in your planning and reporting.

This addon aligns perfectly with the work my organization is doing with AAMI to help drive the acceptance and safety of modern technology in the regulated medical device space. Using automated validation means we don’t need to spend resource time on manually testing and keeping our Jira and Confluence tools in a validated state.