Medical Device Technical File SOP example available?

E

EthanLoh

#11
PHD will be a good to have :lol: Your CER will straight away passed with flying color.
Master degree. Auditor will check page to page.
Normal degree. Auditor will check very sentence.
No degree. Auditor will check every word.:lmao:
 
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Ronen E

Problem Solver
Staff member
Moderator
#12
PHD will be a good to have :lol: Your CER will straight away passed with flying color.
Master degree. Auditor will check page to page.
Normal degree. Auditor will check very sentence.
No degree. Auditor will check every word.:lmao:
Great analysis! :lol:

Now seriously:

A PhD normally indicates some training and some experience in research and in scientific paper writing (including papers review and analysis), which are important skills for compiling a compliant CER.

A Master’s might indicate the same (though sometimes to a lesser extent - “smaller” research), but not necessarily as today some well-esteemed institutes offer Master’s degree routes that don’t include a thesis.

I’m not saying that this is a formal or a practical requirement (I don’t have a PhD and have compiled CERs, excluding the critical review which requires clinical expertise), but I understand why/how it puts auditors’ minds more at ease.
 
K

Karen747

#13
Hi All,

I am reviewing the way in which we control our STED file, at the moment everything is done through our computer drive in a locked folder so only reg can access/edit but really there is not enough control and checking of what is and isn't added.

In regards to maintenance does everyone generally do the same as above and have a checklist to ensure all new items have been updated or would you use a combination of manual control and then some sort of management system?

Really my question is what kind of prompts do you have to make a change to your technical file?

Any tips would be greatly appreciated!!
 

Wolf.K

Quite Involved in Discussions
#14
Currently I am evaluating the impact of the new European Medical Device Regulation. Annex II defines the requirements for the technical file (the CER is part of the technical file). If I come to a conclusion, I will hopefully remember this thread... Currently we have a folder on the QM section of the server and only two people are allowed to update the files.
 
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