O
Ocean12
Hi,
ISO 13485:2016 and the QSR both require a statistical based justification behind the selection of the sampling size in V&V testing.
For one of our V&V tests, we tested 3 samples because we followed an harmonized standard which is specific for this type of test and requires the use of 3 samples.
My question is: will the NB accept the reference to the harmonized standard to justify the selection of 3 samples without any further "statistical" justification? It makes sense to me that the regulatory body that accepts that standard should also accept the sample size of the standard. What do you think about it? What is your experience with you NB or FDA in relation to statistical justification? Thank you for your feedback!
ISO 13485:2016 and the QSR both require a statistical based justification behind the selection of the sampling size in V&V testing.
For one of our V&V tests, we tested 3 samples because we followed an harmonized standard which is specific for this type of test and requires the use of 3 samples.
My question is: will the NB accept the reference to the harmonized standard to justify the selection of 3 samples without any further "statistical" justification? It makes sense to me that the regulatory body that accepts that standard should also accept the sample size of the standard. What do you think about it? What is your experience with you NB or FDA in relation to statistical justification? Thank you for your feedback!