J
We are a european manufacturer of a medical device, class I for FDA, class I for europe.
Exemt from premarket approval, not exemt from GMP.
We received the pre-announcement for a 4 day routine inspection.
We have only 12 employees.
How much of the 21CFR820 will be audited?
Am i correct assuming its a level II inspection?
Is it similar (scope and depth) to a ISO 13485 audit?
Under the MDD, only a few sections are mandatory to class I devices, the scope of the iso 13845 can be reduced.
What about the FDA?
I cant find a list that tells me what sections are not applicable for class I except design control which is applicable since the device contains software.
tx
Exemt from premarket approval, not exemt from GMP.
We received the pre-announcement for a 4 day routine inspection.
We have only 12 employees.
How much of the 21CFR820 will be audited?
Am i correct assuming its a level II inspection?
Is it similar (scope and depth) to a ISO 13485 audit?
Under the MDD, only a few sections are mandatory to class I devices, the scope of the iso 13845 can be reduced.
What about the FDA?
I cant find a list that tells me what sections are not applicable for class I except design control which is applicable since the device contains software.
tx