use-related-risk-analyzer

# Use-Related Risk Analyzer Skill ## Purpose The Use-Related Risk Analyzer Skill identifies and evaluates hazards associated with user interaction with medical devices, implementing IEC 62366-1 usability engineering methodology and supporting human factors risk analysis. ## Capabilities - Use scenario identification - Task analysis decomposition - Use error categorization (perception, cognition, action) - Known use problems database search - Risk mitigation strategy development - Training vs. design solution recommendations - User interface risk analysis - Critical task identification - Use error root cause analysis - Usability test planning support - IFU effectiveness evaluation ## Usage Guidelines ### When to Use - Conducting use-related risk analysis - Planning usability engineering activities - Designing user interfaces - Evaluating training effectiveness ### Prerequisites - User profiles defined - Use environments characterized - Intended use documented - Use scenarios identified ### Best Practices - Integrate with ISO 14971 risk management - Prioritize inherently safe design - Test with representative users - Validate critical tasks ## Process Integration This skill integrates with the following processes: - Human Factors Engineering and Usability - Medical Device Risk Management (ISO 14971) - Verification and Validation Test Planning - Design Control Process Implementation ## Dependencies - IEC 62366-1 standard - FDA Human Factors guidance - AAMI HE75 guide...