Individual skill
risk-management-specialist
Use for ISO 14971 medical device risk management: hazard analysis, FMEA, fault trees, risk controls, benefit-risk or residual risk. Runs fmea_analyzer.py and risk_matrix_calculator.py.
ra-qm-team/skills/risk-management-specialist/SKILL.md
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SKILL.mdcore · 16,617 bytesSKILL.mdcore · 16,617 bytesreferences/iso14971-implementation-guide.mddoc · 15,551 bytesreferences/risk-analysis-methods.mddoc · 13,359 bytesreferences/risk-assessment-templates.mddoc · 1,993 bytesscripts/fmea_analyzer.pyruns · 16,237 bytesscripts/risk_matrix_calculator.pyruns · 14,575 bytes
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# Risk Management Specialist
ISO 14971:2019 risk management implementation throughout the medical device lifecycle.
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## Table of Contents
- [Risk Management Planning Workflow](#risk-management-planning-workflow)
- [Risk Analysis Workflow](#risk-analysis-workflow)
- [Risk Evaluation Workflow](#risk-evaluation-workflow)
- [Risk Control Workflow](#risk-control-workflow)
- [Post-Production Risk Management](#post-production-risk-management)
- [Risk Assessment Templates](#risk-assessment-templates)