How to document discontinuation or end of life for a software version ?

jradford

Involved In Discussions
#1
I do not see anything in the 62304 standard about discontinuing or end of life a software version?? Is there a guidance out there to help with this?

So, we manufacture medical devices. They are operated through software we design and code. This same version of software runs our whole family of medical devices. When we made a change to one of the devices, so we had to make changes to the software. It was determined to increase the version level of the software from version 7 to version 8. So basically version 7 is obsolete and no further upgrades would be made to it. There was not an end of life for the medical device product.

So I would believe there needs to be some report about ending maintenance on version 7 software. Anyone else run into this?

Thanks
 
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c.mitch

Quite Involved in Discussions
#3
Hi,

There is no formal requirement in IEC 62304 about that. You may rely on problem resolution procress, which tells you to inform parties about problems.
However, this is more at the ISO 13485 level, or US QSR level, that obsolescence should be treated, by informing users of the SW obsolescence and the need to upgrade it.
Depending on how you manage the traceability of sold products, this could be very easy, or a nightmare!

There was not an end of life for the medical device product.
This is very astonishing. Most of regulations require to define a device shelf life (even for standalone software, but this is another subject). If there is a shelf life, then all products older that their self life shouldn't be upgraded. Unless you upgrade them as a goodwill gesture.
 
S

Spazz

#4
When we made a change to one of the devices, so we had to make changes to the software. It was determined to increase the version level of the software from version 7 to version 8. So basically version 7 is obsolete and no further upgrades would be made to it.
While I'm not an IEC 62304 expert, this sounds like a revision of existing software and not an end-of-life. It could be handled through your change control procedure and software maintenance plan.
 
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