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Quality and Risk (EVT (Design Review to PRD, Update DFMEA, Verification…
Quality and Risk
EVT
Design Review to PRD
Update DFMEA
Verification Testing
Review factory control plans
HALT, Durability, reliability testing developed
PRD and TRD are locked
FAIR's reviewed
Initial Compliance Evaluation
Factory visits
Research
Proto-Type
Design reviews
Ensure PRD ties to user needs
Decision to proceed
Consumer or Medical
FDA Risk Evaluation
Ideation
Input from Future labs
Applicable Compliance Standards
DVT
PVT (if needed)
Production