Module 14: Design Development and Certification of Medical Devices

17/11/2023

Use-related hazards… and why they arise…

 The use environment impairs the ability of the user to use the device in such a way that the user cannot interact with it  The device is inconsistent with the user’s expectation or intuition about how the device operates.  The device is used in a way that was not anticipated .. Or as anticipated but inappropriately.

Masterclass: Lecture 2

57

Simulated use study of ICU equipment

Masterclass: Lecture 2

58

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