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Articles Questions

July 26, 2020

Do We Have to Re-Do All Software System Tests After a Minor Change?

Dr. Oliver Eidel


We’ve certified and released the first version of our software as a medical device. Now we’re working on a minor update which just fixes some bugs. Do we have to re-do all our software system tests before we can release it? This could be very painful because our testing process involved lots of manual tests.

Short Answer

No, not necessarily. Only re-do the tests for software requirements which were touched by the (code) change. But be sure to document your reasoning.

Long Answer

If only a small part of your code has been changed since your last release, you can just go ahead and check which software requirements and tests are affected by it. Only re-run those. But write down your reasoning somewhere, e.g. in your test plan, where you describe which tests don’t have to be re-done and why.

This is assuming that those tests were on a small (e.g. unit) level. Regarding your integration tests, I’d re-run those to ensure that you haven’t inadvertently broken something. This should be an easy win because your integration tests are usually automated (they are, right?).

The main point of this is to minimize unnecessary human (manual) testing if it’s not necessary.

But this is yet another topic which heavily depends on your auditor. When in doubt, I’d suggest that you make a proposal (write a test plan as described above), send it to them and ask them if that approach would be okay. They aren’t allowed to provide consulting to you but they should be able to give you an indication on whether you can move ahead with your approach or whether it needs more work.

See also my article on software system testing and the software system test plan template.

On a slighty different note: You want to get your medical software certified under MDR but don't know where to start? No worries! That's why we built the Wizard. It's a self-guided video course which helps you create your documentation yourself. No prior knowledge required. You should check it out.

Or, if you're looking for the most awesome (in our opinion) eQMS software to manage your documentation, look no further. We've built Formwork, and it even has a free version!

If you're looking for human help, did you know that we also provide some limited consulting? It's limited because we are not many people. We guide startups from start to finish in their medical device compliance.

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Dr. Oliver Eidel

I'm a medical doctor, software engineer and regulatory dude. I'm also the founder of OpenRegulatory.

Through OpenRegulatory, I've helped 100+ companies with their medical device compliance. While it's also my job that we stay profitable, I try to dedicate a lot of my time towards writing free content like our articles and templates. Maybe that will make consulting unnecessary some day? :)

If you're still lost and have further questions, reach out any time!


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No QMS on this planet will save you from creating crappy software.