Changes

| # Verify that product performance specifications correspond to appropriate design output documents. | | Biomedical engineer, Mechanical engineer|-!rowspan="4"|Risk Management Documents | Review Risk Analysis, Design Failure Modes and Effects Analysis (DFMEA), Process FMEA, other risk management documentation.| | Biomedical engineer|-| Verify that DFMEA links appropriately to the PPS. | | Biomedical engineer, Mechanical engineer|-|-| verify that appropriate DV&V reports and design output documents are reference correctly as risk mitigation activities in the DFMEA. | | Biomedical engineer, Mechanical engineer|-| Similarly verify that PFMEA links appropriately to the process validation protocol acceptance criteria and that in-process inspection procedures and/or manufacturing procedures are recorded as appropriate risk mitigation activities in the PFMEA.