Changes
/* Scenario */
!align = "center" bgcolor = "#00CCFF" width="15%"|Review
!bgcolor = "#00CCFF" width="30%"|Activity
!bgcolor = "#00CCFF" width="40%"|Tasks
!bgcolor = "#00CCFF" width="15%"|Expertise
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!rowspan="2"|Design Input
| Verify if design input documents are sufficient
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# Access electronic data room.
# Compare document list with standard client document list.
# Check whether each specified document has appropriate content.
| Biomedical engineer
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| Verify if these input documents have been adequately linked to the product performance specifications.
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| Biomedical engineer, Mechanical engineer
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!rowspan="3"|Product Performance Specifications (PPS)
| Verify that design inputs correlate adequately to the specifications and that appropriate design verification and validations (DV&V) are performed.
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| Biomedical engineer
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| Also verify if DV&V criteria are based on risk management documentation or if the criteria are based on sound statistical sampling plans.
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| Biomedical engineer, Mechanical engineer
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| # Verify that product performance specifications correspond to appropriate design output documents.
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| Biomedical engineer, Mechanical engineer
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