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Medical Device Software Update in Field of AIMD

#1
Hej together,

haven't been around for a while since the cove was temporarily shut down, but I'm very glad that everything seems to be back on.

We (manufacturer of an active heart implant) and want to update the software of a product that is still under clinical investigation. The new software version has been generated according to standard (62304) developement process. Changes are rationalized, documented and verified. My questions is: What QA measures must be taken at least when updating the software of products that are already in field? We've written an SOP laying out the steps and tests to be performed. We intend to document the tests, the respective results and the person performing the tests in the frame of our configuration management of the individual implants.

Is this sufficient in your eyes? Could we make even "leaner"?

Best regards from Berlin!
 
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yodon

Staff member
Super Moderator
#2
Do you have contingency plans in the event the field update fails (i.e., ensure ability to roll back to a known operational state)? Have you considered all the failure modes of the update and have controls in place to ensure no loss of safety-critical functions?

Not sure I can see any ways to make things leaner.
 
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