Essentials of European Medical Device Regulatory Affairs

Conduct Risk Assessment

Principles

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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

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PREPARATION AND PLANNING

PHASE 1

IdentifyTeam PrepareRiskAssessment Plan

RISK ASSESSMENT Identifyhazards Identify causes Identifyharm List existing 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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