Changes

Ureteral Stent

No bytes changed, 22:49, 3 August 2008
/* Scenario */
!align = "center" bgcolor = "#00CCFF" width="15%"|Review
!bgcolor = "#00CCFF" width="30%"|Activity
!bgcolor = "#00CCFF" width="15%"|Expertise
!bgcolor = "#00CCFF" width="40%"|Tasks
!bgcolor = "#00CCFF" width="15%"|Expertise
|-
!rowspan="2"|Design Input
| Verify if design input documents are sufficient
| Biomedical engineer
|
# Access electronic data room.
# Compare document list with standard client document list.
# Check whether each specified document has appropriate content.
| Biomedical engineer
|-
| Verify if these input documents have been adequately linked to the product performance specifications.
| Biomedical engineer, Mechanical engineer
|
| Biomedical engineer, Mechanical engineer
|-
!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.
| Biomedical engineer
|
| Biomedical engineer
|-
| Also verify if DV&V criteria are based on risk management documentation or if the criteria are based on sound statistical sampling plans.
| Biomedical engineer, Mechanical engineer
|
| Biomedical engineer, Mechanical engineer
|-
|-
| # Verify that product performance specifications correspond to appropriate design output documents.
| Biomedical engineer, Mechanical engineer
|
| Biomedical engineer, Mechanical engineer
|-
|}