Module 14 2022
14/03/2022
Design Control Process
R eview
User Needs
Design Input
Design Process
V erification
Design Output
Medical Device
V alidation
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Design Control Process
Field Validation
Design Inputs
Design Outputs
Market Performance Evidence
Identify Market Need
Design Space Validation
Define Product Requirements
Product Validation Evidence
Knowledge Space Verification
Design Verification Evidence
Detailed Specification
Proof that the product is safe
Design & Process Development
Knowledge Space Exploration
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