Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

General Principles

 Introduces the concept of risk…  2 components

1. The probability of occurrence of harm

2. The consequence of that harm (how severe the harm is)

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“These cows are small…those cows are far away”

The acceptability of risk is influenced by the stake-holders perception

Therefore a standard process to determine risk and risk acceptability is required

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