Module 14: Design Development and Certification of Medical Devices
17/11/2023
RISK ANALYSIS
Hazard Traceability Matrix
No. Hazard
Reasonably foreseeable risk
Hazardous situation
Harm
Po S
Risk acc?
Risk control options analysis
Risk control measure
Verification of effectiveness
Implem?
R-Po
R-S
Risk acceptable?
R - Residual
RISK MANAGEMENT AND RISK ASSESSMENT
November 2023
29
Tools for analysing
1. How can you estimate risk? a) Published standards or articles b) Statistical references c) Tests d) Results of investigations e) Expert assessment IMPORTANT: The probability of occurrence of a hazardous situation is not the same as the probability of occurrence of harm.
RISK MANAGEMENT AND RISK ASSESSMENT
November 2023
30
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