Checklist for MDD to MDR gap analysis

Mikilk

Involved In Discussions
#21
Hello-

I am still trying to fine tune the GSPR content of my GSPR table to show compliance. My question is, does anyone know if we only need to reference/list the testing report document, or both the testing protocol document and the test report document?

Also, is anyone listing the associated SOPs as evidence in the GSPR table?

Any insights will be greatly appreciated.
Thank you!
no, I would say that test report is sufficient, in cases where you do not have it - you can refer to SOP but if you do have test report covers the validation process it should be sufficient
 
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Mikilk

Involved In Discussions
#22
Hi guys, I am very new to this. But I have been handed over the work of converting MDD sop to MDR sop. Can someone please tell me if this is what GAP assessment is?

and please a clear guide for beginners to convert sop.
my career depends on this. Please help. Thanks.
Hi
the gap analysis is a process that companies need to conduct in order to plan the transition from MDD to MDR.
it is not just a matter of an SOP update. you need to review the QMS and finds the gaps that need to be updated, analysis the Technical files, assign a PRRC etc.
 
#23
Did you get help? are you still looking for
Hi guys, I am very new to this. But I have been handed over the work of converting MDD sop to MDR sop. Can someone please tell me if this is what GAP assessment is?

and please a clear guide for beginners to convert sop.
my career depends on this. Please help. Thanks.
Hiya,

Did you get help? are you still looking for information?
 
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