S
Hello!
Regarding Cl. 14 PEMS in 60601-1 3rd Ed., I'm confused as to what would happen if the software is modified or improved upon after testing is done (and a test report is issued). If we follow the requirements, the documentation would be revved up from ones that were inspected.
What sort of changes, if any, need to be reported to the test lab? And what would trigger a retest or re-review of documentation?
I can't seem to find any guidances on this. Has anyone encountered this situation before? I'm assuming that everyone continues working on software after product is released (though I may be wrong
)...
Thanks,
B
Regarding Cl. 14 PEMS in 60601-1 3rd Ed., I'm confused as to what would happen if the software is modified or improved upon after testing is done (and a test report is issued). If we follow the requirements, the documentation would be revved up from ones that were inspected.
What sort of changes, if any, need to be reported to the test lab? And what would trigger a retest or re-review of documentation?
I can't seem to find any guidances on this. Has anyone encountered this situation before? I'm assuming that everyone continues working on software after product is released (though I may be wrong
Thanks,
B
Last edited by a moderator: