IEC 62304 Class A Project

#11
alright, thank you very much. than i understood this correctly.

If there are no external interfaces/no networking, do i have to mention this in the requirements sheet?

thanks.
 
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yodon

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#13
Since you're class A software, an architecture description isn't required - which is normally where you'd put the discussion of interfaces. So you don't need that for 62304 compliance but you will need something. I'd probably recommend a cybersecurity write-up with that assertion, concluding you've implemented sufficient security. That FDA guidance can be used to drive your cybersecurity documentation. (Again, not needed for 62034 compliance so you can postpone that work to focus on 62304).

NEVER give a reviewer access to your git server! :) Seriously, they should never get to that level. At most, they may want to track a change request through implementation but you should always drive.
 

Tidge

Trusted Information Resource
#14
If there are no external interfaces/no networking, do i have to mention this in the requirements sheet?
In your case, I would not include such "negative requirements"; a more appropriate location would be in the system's architecture description.

one question.. does the reviewer need access to our git server?
I am interpreting 'reviewer' as your customer, and not as some 3rd party auditor.
If you have delivered everything necessary to the manufacturer of record (especially the version-controlled executable, documents and the anomalies list) there is no reason to grant access to an internal server. Of course you can make other business arrangements, but the folks who bought from you should know what they need without having to go dig through your records.
 
#15
Alright thank you!

Another question.

-User Requirements, System Requirements and Software Requirements-
What are the differences here?

"System Requirements" are requirements if our software is an part of another software system. Ok. thats not the case.
"User Requirements" are requirements from our customer (for the finished product). Like "Screen X should have Y functionality and show Z image, etc"

But now what are Software Requirements? Like isnt it the same as "User Requirements"? "The software shall have a screen X with Y functionality?" but maybe just more "technical"?

thanks!
 

Tidge

Trusted Information Resource
#16
Think of software as a component of the finished device. The software requirements derive from the higher level system requirements and are those requirements allocated to software.
 
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