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?
If I have 4 groups (i.e. 4 GMDN), shall all of them be sampled to review for initial audit?
Thanks,
Roland
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 groupN > 30 groups: from N/10 + 5 groups a sample
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
If I have 4 groups (i.e. 4 GMDN), shall all of them be sampled to review for initial audit?
Thanks,
Roland