Iso14971 risk analyzer

Skill a5c-ai/babysitter/library/specializations/domains/science/biomedical-engineering/skills/iso14971-risk-analyzer

Comprehensive risk management skill implementing ISO 14971:2019 methodology for medical device risk analysisFrom its SKILL.md

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npx -y skills add a5c-ai/babysitter --skill iso14971-risk-analyzer

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SKILL.md

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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

What ships with it

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