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Medical Device Consulting

Strategy, Feasibility Studies, Development, Regulations, Manufacturing, SCM

Top Level Hazard & Cause

Top Level Hazard & Cause

How can we do better next time?

Severity of HarmInconvenience or temporary discomfortResults in temporary injury or impairment not requiring professional medical attentionResults in injury or impairment requiring professional medical interventionResults in permanent impairment or life-threatening injuryResults in patient or user deathSeverity of Harm

Effect & Harm /

Hazard related use scenario

How can we do better next time?

Probability of occuraence per device device useApproximately 1 in 1 millionApproximately 1 in 10,000 to 1 in 100,000Approximately 1 in 1,000Approximately 1 in 100Approximately 1 in 10Probability of occuraence per device device use

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