Module 14: Design Development and Certification of Medical Devices

17/11/2023

RISK MANAGEMENT

Masterclass: Lecture 2

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RISK MANAGEMENT

◦ …the identification, understanding, control and prevention of failures that can result in HAZARDS when people use medical devices.

◦ When designing a new device, manufacturers are: ◦ Expected to identify possible hazards ◦ Under normal conditions ◦ Under fault conditions

◦ Calculate potential risks ◦ Under both normal and fault conditions

Masterclass: Lecture 2

18

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