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Class II Medical Device Technical File Checklist

S

SteveK

#21
#21
Hi Aniket,

All parts of the technical file are constantly reviewed and updated as necessary (e.g. because of changes to standards, materials, guidelines and regulations, as well as other PMS input), including the ER; this especially the case after a NB review (in my case currently running at 2 TFs per year). The format/structure I use for the TF is accepted by our NB; in fact I have feedback that it is very good.

On the football side I do have a red preference, though I have not been to a match since the Best, Charlton and Alex Stepney days (to show my age up).

Steve
 
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