Module 19 2021

02/06/2021

General Principles

Risk ● Commination of the likelihood of harm occurring and how severe the harm could be. ● For harm to occur there must be a single or multiple series of events where hazards could cause harm. ● Not all hazards will lead to harm ● Not all hazardous situations lead to harm

Probability of Occurrence

Hazard

Harm

Risk

Severity of Harm

Hazardous Situation

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Risk Analysis

• Risk analysis is an iterative process and • It will become more granular and focused as greater experience is gained relating to the device during design and development and post market. • Risk evaluation should be estimated initially with continuous review and justification applied when additional data (and knowledge is available) • Consider existing sources of data available to you, including from similar devices, as long as you take into account the intended purpose

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