You can google "MDSAP Documents",
the first link is the FDA website for MDSAP. All
MDSAP documents listed there.
MDSAP audit will follow process approach, with four primary processes:
1. Management;
2. Measurement, Analysis and Improvement;
3. Design and Development;
4. Production and Service Controls;
And a supporting process
• Purchasing
The MDSAP audit process has two additional supporting processes:
• Device Marketing Authorization and Facility Registration
• Medical Device Adverse Events and Advisory Notices Reporting.
Similar to US FDA inspection method.