Module 14: Design Development and Certification of Medical Devices

17/11/2023

RISK CONCEPTS

RISK MANAGEMENT AND RISK ASSESSMENT

November 2023

27

Estimating RISK for a medical device

 Probability of occurrence of harm (Po)  It’s the harm that matters

 Severity of harm (S)

Always START by assuming that the device is supplied unpackaged and assume that no risk controls are in place…

RISK MANAGEMENT AND RISK ASSESSMENT

November 2023

28

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