Changes
/* Phase 2: Deeper Dive - Design History File Review */
=== Scenario ===
Client wishes to acquire a ureteral stent company. Dolcera provides the following Design History File (DHF) review.
{|border="2" cellspacing="0" cellpadding="4" width="95%"
!align = "center" bgcolor = "#00CCFF"|Phase
!bgcolor = "#00CCFF"|Activity
!bgcolor = "#00CCFF"|Expertise
!bgcolor = "#00CCFF"|Tasks
|-
!rowspan="2"|Design Input
| Verify if design input documents are sufficient
| Biomedical engineer
|
# Access electronic data room.
# Check what documents are provided.
# Compare document list with standard client document list.
# Check whether each specified document has appropriate content.
|-
| Verify if these input documents have been adequately linked to the product performance specifications.
| Biomedical engineer, Mechanical engineer
|
# Access electronic data room.
# Check what documents are provided.
# Compare document list with standard client document list.
# Check whether each specified document has appropriate content.
|-
|}
=== Review: Design Input ===
# Verify if design input documents are sufficient.
