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!rowspan="3"|Product Performance Specifications (PPS)
| Design inputs correlate adequately to the specifications; DV&V (design verification and validation) criteria are based on risk management documentation or if the criteria are based on sound statistical sampling plans
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# Compare product specifications to design inputs
| Risk Analysis, Design Failure Modes and Effects Analysis (DFMEA), Process FMEA, other risk management documentation
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# Is Check whether documentation is available?# Does Check whether it adhere adheres to appropriate ISO 14971 standards?# Does Check whether it adhere adheres to appropriate client standards?
|rowspan="4"| Quality systems
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| DFMEA links appropriately to the PPS
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# Verify whether DFMEA and product specifications are correlated
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| Appropriate DV&V reports and design output documents are reference referenced correctly as risk mitigation activities in the DFMEA
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# Validate the process and correlate with design inputs
# Validate the ranges that sizes 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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# Validate the process protocol
# Validate the inspection procedures used
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!rowspan="2"|Design Output Documents
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# Check the entire equipment-related lifecycle
# Was Check if machine operational qualification was performed?# Was Check if the measurement equipment was validated?
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!rowspan="2"|Validation Report
| DV&V reports, Shelf-life reports, Biocompatibility test reports, Sterilization reports, Packaging Validation reports, Process Validation Reports
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# Ensure all reports are available and linked together appropriately# Identify all inconsistencies across different reports
| rowspan="2"|
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| Design test methods and related test method validations
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# Compare test methods used to those in client and ISO standards
# Identify inconsistencies across test methods
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