Links
• GHTF Quality Management Systems - Process Validation Guidance: www.imdrf.org/d...
• Medical Device Single Audit Program (MDSAP) Audit Approach: www.fda.gov/me...
o Chapter 3: Tasks 7
o Chapter 6: Tasks 7, 8, 9, 11, 13, & 15
• 21 CFR 820.75: www.accessdata...
• ISO 13485:2016: www.iso.org/st...
• Quality System Regulation Process Validation, Joseph Tartal: www.fda.gov/me...
Requirement name and location
Our topic, Performance Qualification, is covered by 820.75 and 13485 Section 7.5.6. For more detailed information on process validation and Performance Qualification go to the GHTF document.
Performance Qualification in 5 words:
Production Runs Prove Consistent Output