Verify Software System Testing: Verify that results meet the Pass/Fail Criteria




I'm new to IEC 62304 and medical device software development.

Chapter 5.7.4 "Verify SOFTWARE SYSTEM testing" in the 62304 standard states:
"The manufacturer shall verify that
a) The VERIFICATION strategies and the test procedures ...
b) ...
c) ...
d) test results meet the required pass/fail criteria

My question is: How to interpret this last item ?
Does this mean that results have to be reviewed AFTER tests were executed ?
Or would a review of test case's steps and expected results BEFORE execution be sufficient


Marcelo Antunes

Addicted to standards
Staff member
Hello sope01 and welcome to the Cove!

First you have to define what and why you are testing. Then you need to define how to you verify that the test is passed (pass/fail criteria).

Then you perform test. Then you analyze the results and concludes if the test is passed or not.

This in fact is not only applicable to software, but to anything that needs to be verified.

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