Module 14: Design Development and Certification of Medical Devices
17/11/2023
What is Design Control?
R eview
User Needs
Design Input
Design Process
V erification
Design Output
Medical Device
V alidation
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Whatis Design Control?
Identify Needs
Design & Process Development
Market Entry
Process of Design
Mitigation through design
Mitigation through manufacture Risk (PMS)
Risk
Define Product Requirements
The Design
Detail Specification
Design Freeze
Design Control
The Design - Dimensions/Tolerances - Critical Quality Attributes
Process of Design - Process control - 21 CFR 820.30 - ISO 13485 / ISO 9001
Risk
- RMP - Risk Analyses - FMEA -
- Specifications - Data/Drawings
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