MDSAP Stage 1 Guidance Documents

[kreid]

Hello,

I have been looking at the MDSAP guidance on the FDA website (MDSAP Assessment Procedures and Forms) and the guidance on the Stage 1 audit seems to be focussed on the auditing of the Auditing Organisation (and not the manufacturer). The guidance document series reference starts with MDSAP AS P/F0013.

Am I reading this incorrectly?

 

[SylvieS]

True - those are not the documents for the auditing organization auditing a medical device manufacturer, but the documents in order to audit the auditing organization.