Best Test Case Management Tool for Medical Device Testing

Hello Testers,

I have recently made the transition into medical device testing and am in search of a good test case management tool that works well with regulatory processes. My team has traditionally used word documents to track test cases. Some things I am looking for are:

  • The ability to easily have a team review the test case and give input

  • The ability to export test cases and test case results in a very clear and legible format (ideally in word or as a pdf). These documents are submitted for regulatory review.

  • Integration with automated test scripts written in python

  • The ability to see an audit history of the test case

  • The ability to see pass/fail history on a test case

  • General reporting of test run results

*Ability to integrate with Azure DevOps is a big plus

Thanks!

hi Carly,

I cannot tell you what is best for you :wink: but here are some ideas:

Microsoft Azure DevOps - the test module… Read https://azure.microsoft.com/en-us/blog/new-azure-gxp-guidelines-help-pharmaceutical-and-biotech-customers-build-gxp-solutions/ or https://docs.microsoft.com/en-us/microsoft-365/compliance/offering-fda-cfr-title-21-part-11?view=o365-worldwide

Most other specific test case management tools ( like PractiTest, a MoT sponsor :wink: ) have a response to CFR-11 / GxP / regulatory audit.

Set up an activity to review & evaluate 2-4 tools based on the above and set up a purchasing process within your company.

Hope this helps you along :slight_smile: /Jesper

2 Likes

Hi @averoqa,
first I would advise you to try a few tools first; several have sandboxes so you don’t even have to install them on your environment.
Second, Xray covers all those points; it now comes with a built-in document generator that can export testing assets to doc or pdf.
You can see a success case for a medical device manufacturer (if that helps).

In the following link you may find dozens of automation tutorials, for different languages: https://confluence.xpand-it.com/display/XRAY/TTT%3A+Automation

They’re basic and not perfect but they show how you can integrate with different frameworks.
Concerning Azure DevOps, you can see here a tutorial showcasing it :slight_smile: https://confluence.xpand-it.com/display/XRAY/Integration+with+Azure+DevOps

Btw, we now have a free exploratory testing tool; you don’t need Xray to use but I strongly advise you to try it out: https://xr4y.io/explore

Disclaimer: I work for Xray :wink: anything, let me know.

Regards,
Sergio