Essentials of European Medical Device Regulatory Affairs - October 2019
Conduct Risk Assessment • Principles
What can go wrong?
How often?
How bad?
Do I need to do something?
What do I need to do?
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Conduct Risk Assessment • 3 phases
PREPARATION AND PLANNING IdentifyTeam PrepareRisk AssessmentPlan
PHASE 1
RISK ASSESSMENT Identifyhazards Identify causes Identifyharm Listexisting controls Assess risk
PHASE 2
Determine risk acceptability Develop recommendations
REVIEW AND FOLLOW- UP Review recommendations Implement additional measures Re-assess risk
PHASE 3
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