Module 14: Design Development and Certification of Medical Devices
17/11/2023
Design Control Process
R eview
User Needs
Design Input
Design Process
V erification
Design Output
Medical Device
V alidation
The Organisation for Professionals in Regulatory Affairs
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Design Control Process
Field Validation
Design Inputs
Design Outputs
Market Performance Evidence
Identify Needs
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
The Organisation for Professionals in Regulatory Affairs
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