Essentials of European Medical Device Regulatory Affairs

Conduct Risk Assessment • Principles

What can go wrong?

How often?

How bad?

Do I need to do something?

What do I need to do?

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