Module 14 2022

22/03/2022

RISK MANAGEMENT

WHAT IS IT? ● 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

The Organisation for Professionals in Regulatory Affairs

9

RISK MANAGEMENT

IF A RISK IS JUDGED TO BE UNACCEPTABLE…?

IT MUST BE ELIMINATED 0R REDUCED TO ACCEPTABLE LEVELS

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Masterclass: Lecture 2

The Organisation for Professionals in Regulatory Affairs

10

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