Template: Software System Test Plan

Dr. Oliver Eidel IEC 62304 Templates Published June 09, 2022

Template Download

This is a free template, provided by OpenRegulatory.
If you are a user of Formwork, our eQMS software, you can save a lot of time by choosing “QMS” on the top menu and “OpenRegulatory Templates” on the left menu, then opening the relevant folder to find this template ready to load into Formwork.

If, for some mysterious reason, you're using a different QMS software, you can also simply download this template – specifically, as Word (.docx), PDF, Google Docs or Markdown file. Scroll down for a preview!

The template license applies (don't remove the copyright at the bottom, don't re-use this for commercial purposes).

Lost In Regulation? We're here to help.

Unsure how to get started and how to get your EU MDR medical device certified?
We've already helped 100+ companies with their MDR compliance.
Take a look at our services and book a free 30-minute consulting call.

Template Preview

Software System Test Plan

SR ID refers to the ID of the software requirement which is tested by this test.

Note that this is, strictly speaking, not a "plan" because it already includes the results (columns "Actual"
and "Pass?"). To keep things clean, I'd suggest splitting this table up into a "plan" and a "protocol"
(suggestion by a friendly auditor). The plan contains all columns below except "Actual" and
"Pass?". The protocol contains all columns. The idea is this: It makes sense to write the plan before
actually doing the testing. You don't want to be changing the test steps when you notice your tests are
failing (surely nobody would do that). So you write the plan first, finalize it, then copy-paste it to a
protocol in which you enter the results after you've done your tests.

ID SR ID Description Steps Expected Actual Pass?
1 1 Login with correct email and password succeeds 1. Enter email [email protected]. Enter password atari3. Click login Redirect to account page Redirect to account page Pass
2 1 Login with incorrect email and password fails 1. Enter email [email protected]. Enter password butterfly3. Click login Error "invalid credentials" displayed Error "invalid credentials" Pass

Template Copyright openregulatory.com. See template
license
.

Please don't remove this notice even if you've modified contents of this template.

Dr. Oliver Eidel avatar

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!