iso14971-risk-analyzer

# ISO 14971 Risk Analyzer Skill ## Purpose The ISO 14971 Risk Analyzer Skill implements comprehensive risk management methodology per ISO 14971:2019 for medical devices, supporting hazard identification, risk estimation, risk control, and benefit-risk analysis throughout the device lifecycle. ## Capabilities - Hazard identification questionnaire generation - Hazardous situation analysis templates - Risk estimation matrix configuration - Risk acceptability criteria setup - Risk control measure tracking - Residual risk evaluation - Benefit-risk analysis documentation - Risk management plan templates - Risk management report generation - Post-production risk monitoring - Risk control verification tracking ## Usage Guidelines ### When to Use - Establishing risk management plans - Conducting hazard analyses - Evaluating risk acceptability - Documenting benefit-risk determinations ### Prerequisites - Device intended use defined - Reasonably foreseeable misuse identified - Risk acceptability criteria established - State of the art research completed ### Best Practices - Begin risk management at concept phase - Maintain risk management file throughout lifecycle - Review risks at each design phase gate - Integrate with post-market surveillance ## Process Integration This skill integrates with the following processes: - Medical Device Risk Management (ISO 14971) - Human Factors Engineering and Usability - 510(k) Premarket Submission Preparation - EU MDR Technical Documentatio...