The Medical Devices Introductory Course 2020

Introduction All stakeholders need to understand that the use of a medical device entails some degree of risk.

Each stakeholder’s perception of the risk can vary greatly depending upon:

The acceptability of a risk to a stakeholder is influenced by:

socio- economics

culture

the probability of occurrence of harm

consequenc es of that harm / how

severe it might be

actual / perceived health

education

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Introduction

The way a risk is perceived also takes into account whether exposure to the hazard seems to be:

due to negligence

involuntary

avoidable

poorly understood cause

directed at vulnerable group

man-made

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