Module 14: Design Development and Certification of Medical Devices

17/11/2023

HUMAN FACTORS…

HUMAN ERROR IS THE CAUSE OF MOST ACCIDENTS… ◦ Some sources state that human error is the cause in 90% of accidents!

◦ In the medical device environment, such errors can cause serious injury or death

◦ THE DESIGN TEAM MUST HAVE A GOAL OF ENSURING THAT ANY DEVICE IS EASY AND SAFE TO USE.

Masterclass: Lecture 2

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Use-related hazards…

Masterclass: Lecture 2

54

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