Module 14: Design Development and Certification of Medical Devices

17/11/2023

Human factors studies are very important in risk assessment

Masterclass: Lecture 2

55

Use-related hazards…. and why they arise…

 Use of the device requires:  physical, perceptual or cognitive abilities that exceed the abilities of the user  The use environment affects operation of the device  this is not properly recognised or understood by the user.

Masterclass: Lecture 2

56

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