Module 14: Design Development and Certification of Medical Devices

17/11/2023

RISK ASSESSMENT … is an iterative process..

RISK = PROBABILITY +SEVERITY

Masterclass: Lecture 2

35

Inherent elements of RISK

◦ Use in / for patients ◦ Requires human intervention ◦ Design and performance ◦ Misuse and abuse

Masterclass: Lecture 2

36

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