Module 14: Design Development and Certification of Medical Devices

17/11/2023

THE RISK MANAGEMENT PROCESS

Masterclass: Lecture 2

43

RISK ANALYSIS / RISK EVALUATION

 Determine the level of risk  High, medium, low  Identify and list characteristics that could affect safety  Identify associated hazards  Arising from correct intended use  And from foreseeable mis-use  Determine the potential SOURCE or CAUSE of the hazard  Assign a level of risk to each identified hazard  Plus probability and severity

Masterclass: Lecture 2

44

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