Module 14 2022

22/03/2022

Human factors studies are therefore a very important factor in risk assessment

Masterclass: Lecture 2

The Organisation for Professionals in Regulatory Affairs

31

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

The Organisation for Professionals in Regulatory Affairs

32

16