Section
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