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" width="15%"|PhaseReview
!bgcolor = "#00CCFF" width="30%"|Activity
!bgcolor = "#00CCFF" width="15%"|Expertise
| 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.| 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| |-|-| # Verify that product performance specifications correspond to appropriate design output documents. | Biomedical engineer, Mechanical engineer|
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