Technical Files Sampling Rule defined in NBOG 2009-4

Roland chung

Trusted Information Resource
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

If I have 4 groups (i.e. 4 GMDN), shall all of them be sampled to review for initial audit?


Ronen E

Problem Solver
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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