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