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