Technical Files Sampling Rule defined in NBOG 2009-4

R

Roland chung

Trusted Information Resource
#1
#1
Hi all,

How do you interpret the technical files sampling plan for Class IIb medical devices defined in the NBOG 2009-4?


Up to 2 groups: a sample from each group
Up to 10 groups: a sample from 3 of these groups
Up to 20 groups: a sample from 5 of these groups
Up to 30 groups: from 7 groups a sample​
N > 30 groups: from N/10 + 5 groups a sample
Click to expand...
If I have 4 groups (i.e. 4 GMDN), shall all of them be sampled to review for initial audit?

Thanks,
Roland
 
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Ronen E

Ronen E

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#3
#3
The way I read the quote, 3 groups would be selected (in random, I suppose) out of the 4, then a sample of each would be reviewed.
 
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