Manufacturing flowchart SaMD

[TomQA]

Hello,

the MDR requires us to create a "Manufacturing flowchart" of our medical device. If the medical device is a SaMD : what would be the manufacturing flowchart ?
Thanks !

 

[yodon]

Can you point to the specific MDR requirement so I (we) have full context?

 

[TomQA]

It comes from the Team-NB position paper on MDR technical documentation guidance.



It was also mentioned in our notified body's guidance.
Thanks!

 

[yodon]

Ah, ok, that helps tremendously.

I'm sure your NB would recognize that there's no "manufacturing processes" per se with software. I would probably still have this section, though, and note that it's a software-only product and reference the build documentation (which should provide sufficient information about the build environment controls and enable a re-build in the future!). Maybe even reference the Software Development Plan which outlines how releases are controlled. I would also describe how I ensure that the binaries from the build get to the right place and are confirmed correct. Should be pretty simple.

 

[DanMann]

I've referred to procedures for upload/release of software into cloud environments/repositories and confirmation of their successful upload as "implementation" documents to contrast with "manufacturing" of physical objects (or even physical media containing software) and linked all of these to the same requirements.

 

[TomQA]

Thanks all for your inputs!

 

[Berto_gi]

@TomQA : Would be good to know how you proceeded here and if your NB was satisfied with the rationales as presented by Yodon and DanMann. Thanks

 

[DanMann]

@TomQA : Would be good to know how you proceeded here and if your NB was satisfied with the rationales as presented by Yodon and DanMann. Thanks

Accepted by two NBs.