A relatively new FDA abbreviated 510(K) guidance is published and I was wondering if anyone has assessed the gap analysis or created a summary report to state if the updated guidance is applicable to their QMS. Can you please share some ideas or scrubbed version? Thanks!
Can someone help me how this change will effect in "510K" procedures. I am updating our SOP's based on this update.
As well as "notification of changes to Regulatory agencies (EU/US) procedures.
