Essential Requirements Of A Technical File - ISO13485 / Health Canada / MDD

T

TJG954 - 2009

#1
I'm in the middle of our stage one ISO13485/Health Canada/MDD audit. The auditor stated that there is a published list of the specific documents that must be included in the Technical File we forward to our notified body in Europe. I was hoping someone had that list and would share it with me.


PS... these auditors sure know how to push the right buttons. :bonk:


Thanks in advance. Ted
:thanks:
 
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Ajit Basrur

Staff member
Admin
#2
T

TJG954 - 2009

#3
Re: Essential Requirements Of A Technical File

Thank you! It's just what the doctor ordered!!!

If I'm still here on Friday, I'll let you know how we did.

There are sooooo many smilies I could use at this point....

:mg: :( :mad: :confused: :lmao: :bonk: :frust: :nope: :truce: :argue: :whip: and last, but not least...:nopity:
 

GStough

Staff member
Super Moderator
#4
Re: Essential Requirements Of A Technical File

Thank you! It's just what the doctor ordered!!!

If I'm still here on Friday, I'll let you know how we did.

There are sooooo many smilies I could use at this point....

:mg: :( :mad: :confused: :lmao: :bonk: :frust: :nope: :truce: :argue: :whip: and last, but not least...:nopity:
Hang in there, Ted! I'm sure you'll do better than you think. :agree1: Of course, we'll all be here waiting to hear how it went, so don't leave us hanging! ;)
 

Ajit Basrur

Staff member
Admin
#5
Re: Essential Requirements Of A Technical File

Hi Ted,

Glad to note that our diagnosis was "Dead on".

As Gidget rightly pointed, do not leave us hanging :tg:
 
T

TJG954 - 2009

#6
Re: Essential Requirements Of A Technical File

Middle of Stage Two. I should have the results Friday afternoon. :agree1:

THANKS for your support!

Ted
 
R

Roland Cooke

#7
Re: Essential Requirements Of A Technical File

It's not a bad list.

Photos! God, yes. :D 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."
 
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