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 Documentation

Dependencies

• ISO 14971:2019 standard
• Risk matrix templates
• Hazard databases
• Safety standards (IEC 60601, IEC 62366)
• Post-market data sources

Configuration

iso14971-risk-analyzer:
  risk-categories:
    - clinical
    - electrical
    - mechanical
    - software
    - biocompatibility
    - sterility
    - usability
  probability-levels: 5
  severity-levels: 5
  acceptability-criteria:
    ALARP: true
    state-of-art: true

Output Artifacts

• Risk management plans
• Hazard analysis worksheets
• Risk estimation matrices
• Risk control documents
• Residual risk evaluations
• Benefit-risk analyses
• Risk management reports
• Risk control verification records

Quality Criteria

• All reasonably foreseeable hazards identified
• Risk estimation is systematic and documented
• Risk control measures are verified effective
• Residual risks are acceptable per criteria
• Benefit-risk analysis supports intended use
• Documentation meets ISO 14971:2019 requirements