Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

General Principles

 Hazardous Situation ● Can result from normal and abnormal use of the device ● Hard to identify ● Complexities of multiple hazardous situations acting together ● Risk estimation can be difficult ● Emphasis must be on implementation of a robust system to prevent failures

Random Faults

Hazardous Situation

Systemati c Faults

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General Principles

 Harm ● Consideration to safety of patient, operator, property or environment ● Hazardous situations may result in multiple harm ● Complex relationship to hazard ● Dependent on how, why, where and who uses the device

Random PaFapue lrtsCut

Something in between..??

Death

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