Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Practical Implementation

 The risk management process...?

Witchcraft Happens

Risk Identification

Risks Acceptable

The Organisation for Professionals in Regulatory Affairs

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Practical Implementation

Intended Use Intended Purpose

Risk Analysis

State of the Art

Risk Evaluation

 Or....

Risk Assessment

Risk Control

 A systematic approach  Throughout product life-cycle  Evidence Based  Continuous Process

Evaluation of Residual Risk

Risk Reporting

Risk Management

Post Production Review

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