Changes

# Check whether appropriate verifications and validations are performed

# Establish if all specifications are linked to design inputs

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| Appropriate design verification and validations (DV&V) are performed

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# Show DV&V criteria are based on risk management requirements

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| Product performance specifications correspond to appropriate design output documents

# Correlate design drawings with the specifications

# Check whether maximum dimensions, sizes etc. (with tolerances) are within the specified range

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!rowspan="4"|Risk Management Documents

# Does it adhere to appropriate ISO 14971 standards?

# Does it adhere to appropriate client standards?

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| 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

# Validate the process and correlate with design inputs

# Validate the ranges used are within range of risk mitigation criteria

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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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!rowspan="2"|Design Output Documents

# Check if the CAD diagrams overlay and "fit" perfectly

# Check tolerance stackups

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| Correlate First Article Inspection data to the dimensions on the drawings