Module 14 2022

22/03/2022

Inherent elements of RISK

● Design and performance – Day to day performance and reliability – Choice of materials – Manufacturing consistency ● Misuse and abuse – …the device may not be actually used as intended…

Masterclass: Lecture 2

The Organisation for Professionals in Regulatory Affairs

7

RISK MANAGEMENT

Masterclass: Lecture 2

The Organisation for Professionals in Regulatory Affairs

8

4

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