Module 14: Design Development and Certification of Medical Devices

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17/11/2023

What is RISK MANAGEMENT?

 Your risk management process must cover the WHOLE lifecycle of your device

Lifecycle management

Risk analysis

Risk evaluation

Risk control

RISK MANAGEMENT AND RISK ASSESSMENT

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What is RISK MANAGEMENT?

 The lifecycle risks…

Everyday use

End of life support

Transport & Distribution

Concepts

Design

Production Sterilisation

Installation

Training

RISK MANAGEMENT AND RISK ASSESSMENT

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