MDSAP Audit Procedures and Forms
MDSAP AU P0002
MDSAP AU P0008
- MDSAP AU P0008.007: Audit Time Determination Procedure
- MDSAP AU F0008.2.002 Audit Duration Calculation Form (Audit Model 2017)
MDSAP AU P0019
- MDSAP AU P0019.004 Medical Device Regulatory Audit Reports Policy
- MDSAP AU F0019.1.008 Medical Device Regulatory Audit Report
- MDSAP AU F0019.2.011 NC Grading and Exchange Form
- MDSAP AU G0019.3.007 Medical Device Regulatory Audit Report Form Guidelines
- MDSAP AU G0019.4.004 Guidelines NC Grading Exchange Form
MDSAP AU P0026
- MDSAP AU P0026.003 Certificate Document Requirements
- MDSAP G0026.1.004 Surveillance Audit Confirmation Notification Process
MDSAP AU P0027
- MDSAP AU P0027.006 Post Audit Activities and Timeline Policy
- MDSAP AU G0027.1.001 Audit Report Submission in Box
MDSAP AU P0028
MDSAP AU P0029
- MDSAP AU P0029 005 Communication by AOs with RA on Organizations Participating in MDSAP
- MDSAP AU G0029.1.001 Guidelines Using ML Update Form
- MDSAP AU F0029.1.001 Master List Form (Please download and open with Adobe Acrobat or Adobe Reader)