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# Is documentation available?
# Does it adhere to appropriate ISO 14971 standards?
# Does it adhere to appropriate client standards?
| Quality systems
| DFMEA links appropriately to the PPS
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# Verify
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| Appropriate DV&V reports and design output documents are reference correctly as risk mitigation activities in the DFMEA
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# Validate the process and correlate with design inputs# Validate the ranges used are within range of risk mitigation criteria|Quality systems
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| PFMEA links appropriately to the process validation protocol acceptance criteria; In-process inspection procedures and/or manufacturing procedures are recorded as appropriate risk mitigation activities in the PFMEA
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|Quality systems
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!rowspan="2"|Design Output Documents