Module 14 2022

14/03/2022

What is Design Control?

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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What is Design Control?

Identify Market Need

Design & Process Development

Market Entry

Process of Design

Mitigation through design

Mitigation through manufacture Risk (PMS)

Risk

Define Product Requirements

The Design

Detailed 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

The Organisation for Professionals in Regulatory Affairs

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