Regulation / Requirements about dump/crash files for medical device software

alimary15

Involved In Discussions
#1
Hello everyone,

I am trying to research whethere there is any applicable requirement or regulation regarding collecting and saving crash log files from software that is classified as a medical device.

I would like to know if it is a requirement to keep track of such dump/crash reports and if so, where such requirement is addressed.

I hope someone can help!

Thanks
 
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Pads38

Trusted Information Resource
#2
I would suggest that this is covered in Clause 9 of IEC62304 - Software problem resolution process. That creates 8 "tasks" required for problem resolution, but does not explicitly mention dump reports.
 
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