Changes

Ureteral Stent

345 bytes added, 04:45, 4 August 2008
/* Review components */
# Compare product specifications to design inputs
# Check whether appropriate verifications and validations are performed
# Establish if all specifications are linked to design inputs| Quality systems
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| Appropriate design verification and validations (DV&V) are performed
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# Show DV&V criteria are based on risk management requirements|Quality systems
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| Product performance specifications correspond to appropriate design output documents
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# Correlate design drawings with the specifications# Check whether maximum dimensions, sizes etc. (with tolerances) are within the specified range|Quality systems, CAD
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!rowspan="4"|Risk Management Documents
| Risk Analysis, Design Failure Modes and Effects Analysis (DFMEA), Process FMEA, other risk management documentation
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# Is documentation
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| DFMEA links appropriately to the PPS
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