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Regulation / Requirements about dump/crash files for medical device software
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Regulation / Requirements about dump/crash files for medical device software
Regulation / Requirements about dump/crash files for medical device software
Regulation / Requirements about dump/crash files for medical device software
Regulation / Requirements about dump/crash files for medical device software
Regulation / Requirements about dump/crash files for medical device software
Regulation / Requirements about dump/crash files for medical device software
Regulation / Requirements about dump/crash files for medical device software
Regulation / Requirements about dump/crash files for medical device software
Regulation / Requirements about dump/crash files for medical device software
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iec 62304 - medical device software life cycle processes, software medical devices
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  Post Number #1  
Old 2nd December 2014, 03:51 AM
alimary15's Avatar
alimary15

 
 
Total Posts: 39
Please Help! Regulation / Requirements about dump/crash files for medical device software

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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  Post Number #2  
Old 2nd December 2014, 08:16 AM
Pads38

 
 
Total Posts: 741
Re: Regulation / Requirements about dump/crash files for medical device software

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.
Thanks to Pads38 for your informative Post and/or Attachment!
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