T
tll120
Hi All,
If a company recently had its ISO 13485 decertified by its Notified Body, does the Notified body inform the FDA? Also, would this information preclude the FDA from reviewing new 510(k)s from this company?
Thank you!
TLL120
If a company recently had its ISO 13485 decertified by its Notified Body, does the Notified body inform the FDA? Also, would this information preclude the FDA from reviewing new 510(k)s from this company?
Thank you!
TLL120