Module 14 2022

22/03/2022

The relationship between HAZARD sequence of events,

HAZARDOUS SITUATION and HARM

(from ISO/IEC Guide 63:2019)

The Organisation for Professionals in Regulatory Affairs

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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

The Organisation for Professionals in Regulatory Affairs

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