a5c-ai 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