Auditor MDR (Presub audit) finding

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#1
We wrote an MDR transition plan about 2 years ago and as we progressed it was not fully updated. We moved our operations into change notices and forgot to update our plan with a few details.

Is an MDR transition plan required?

Ed
 
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chris1price

Trusted Information Resource
#2
There is no requirement in any of the standards or regulations for an MDR transition plan. The only requirement might be if you have raised a change control that says you will have one.
 

mihzago

Trusted Information Resource
#3
I guess that could be a finding under the Quality Planning, but unless your plan was somehow deficient or you failed to properly implement the MDR requirements , I’m not sure why that would be an NC.
 
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