F
fondantcookie
Hi all,
Please can someone tell me the difference between the FDA requirements for Medical Device/IVD manufacture; regarding MDSAP and the CFR regulations.
Ie, if we do a gap analysis against MDSAP, are we essentially "FDA compliant" or are there additional clauses outside of MDSAP that we need to address?
As a background, we have an upcoming MDSAP audit (which we are currently prepping for) but we also want to make an application to list our site/product with the FDA later in the year...
Just want to make sure there isn't a duplication of effort here...
Cheers
HUGE thank you in advance.
Please can someone tell me the difference between the FDA requirements for Medical Device/IVD manufacture; regarding MDSAP and the CFR regulations.
Ie, if we do a gap analysis against MDSAP, are we essentially "FDA compliant" or are there additional clauses outside of MDSAP that we need to address?
As a background, we have an upcoming MDSAP audit (which we are currently prepping for) but we also want to make an application to list our site/product with the FDA later in the year...
Just want to make sure there isn't a duplication of effort here...
Cheers
HUGE thank you in advance.