S
sope01
Hi,
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
Thanks
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
Thanks