USE RELATED RISK ASSESSMENT

Require support with your Use Related Risk Assessment to identify known or foreseeable hazards and identify hazard-related use scenarios?

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We apply a systematic approach to identifying use-related risks, ensuring effective mitigations are implemented and traceable throughout the development process, to support safe and effective device use. Working to ISO 14971-2019.

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Example Methods / Tools:

• Hierarchical Task Analysis (HTA),

• Known Problems Analysis (KPA),

• Perception Cognition Action (PCA) Analysis,

• Use Failure Mode and Effects Analysis (uFMEA),

• Hazards and Hazardous Situations analysis