Re: Essential Requirements Of A Technical File
It's not a bad list.
Photos! God, yes.

I've lost count of the number of times I have struggled to understand what the hell I was actually trying to review!
I would however question dumping risk analysis and clinical data at the end. Those documents are not afterthoughts!
They really should be key to the whole Technical File. After all you are trying to put forward the strongest, easiest-to-understand, case you can make that the device is safe and effective for the intended use.
Additionally, they should probably be linked documents anyway - you are trying to demonstrate the benefit outweighs the risk. Having separate documents without a linking final conclusion (aka "clinical evaluation") is a bit weak.
I've gone off Essential Requirements Checklists over the years; they get very misused. However I do like the concept of putting the Checklist at the
back of the File, as a kind of final sign-off:
"Well all the preceeding stuff demonstrates safety and effectiveness, but here's a final, brief 'index' which confirms we didn't miss anything."