Risk analysis
Develop a comprehensive medical device task analysis and use-related risk analysis (URRA) in alignment with ISO 14971.
Task analysis
A task analysis is a detailed step-by-step breakdown of user interactions with your medical device to understand the context of use and potential friction points.
Identification of all device user tasks
Mapping to perception and cognition demands
Foundation of use-related risk analysis
Aids in the development of labelling material
Use-related risk analysis
Develop a use-related risk analysis to systematically identify potential use errors, harms, and associated design mitigations.
Compliant with ISO 14971, FDA, and IEC 62366
Identification of foreseeable use errors and abnormal use
Design medical devices that are safe, effective and intuitive
Risk evaluation and severity categorization
Crucial input for risk control measure development
Risk mitigation strategy
Develop and implement effective risk control measures through device design, protective measures, or safety information.
Design optimization to eliminate use errors
Traceability between risks and mitigations
Reduction of residual risk to acceptable levels
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