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risk-management-specialist

Implements ISO 14971 risk management workflows for medical device lifecycle documentation.

1|Updated Jul 13, 2026
Search Tags:#risk management#medical device#iso 14971#hazard analysis#risk matrix#fmea#alarp
One-click install
npx skills add https://github.com/HalseyYang/Skills-HY --skill risk-management-specialist-halseyyang
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: risk-management-specialist
Source: https://github.com/HalseyYang/Skills-HY/tree/main/risk-management-iso14971
Command: npx skills add https://github.com/HalseyYang/Skills-HY --skill risk-management-specialist-halseyyang

SYSTEM DOCUMENTATION & REQUIREMENTS

💡 This Skill includes scripts (resource) and references (resource) components.

What problem does it solve? Medical device teams must implement ISO 14971:2019 risk management across the full product lifecycle, but building risk management plans, hazard analyses, FMEAs, and post-market review records from scratch is slow and error-prone. This Skill provides structured workflows, templates, and a risk matrix calculator to produce compliant risk management documentation. ## Core Features & Use Cases - End-to-End ISO 14971 Workflows: Step-by-step processes for risk management planning, risk analysis, risk evaluation, risk control, and post-production monitoring, each with validation checkpoints. - Analysis Methods & Templates: Detailed guidance for FMEA, FTA, HAZOP, Use Error Analysis, and Software Hazard Analysis, plus ready-to-use worksheets for hazard analysis, risk control records, and risk management reports. - Risk Matrix Calculator: A Python script that computes ISO 14971 5x5 risk levels and FMEA RPN values with interactive mode and JSON output. - Use Case: A quality engineer preparing a risk management file for a new infusion pump can follow the risk analysis workflow, run the calculator to classify each hazard's risk level, and generate the risk management report using the provided template. ## Quick Start Ask the assistant to create an ISO 14971 risk management plan and hazard analysis worksheet for your medical device, including a 5x5 risk acceptability matrix.

Frequently Asked Questions about risk-management-specialist

High-intent search queries and answers about installing and using this skill.

FAQPage Schema
How do I create an ISO 14971 risk management plan?▼

Define the device scope and lifecycle stages, establish probability and severity criteria with a 5x5 risk acceptability matrix, assign responsibilities, and plan verification and post-production activities. The Skill provides a complete plan template with approval sections.

How do I calculate FMEA RPN for medical device risks?▼

Multiply Severity, Occurrence, and Detection ratings (each 1-10) to get the Risk Priority Number. The included risk_matrix_calculator.py script computes RPN via command line and assigns priority levels, with RPN above 200 requiring immediate action.

What is the difference between FMEA and FTA in risk analysis?▼

FMEA is a bottom-up method analyzing component failure modes and their effects, per IEC 60812. FTA is a top-down deductive method per IEC 61025 that identifies combinations of events leading to a defined top-level failure, including cut sets and single points of failure.

When is a benefit-risk analysis required under ISO 14971?▼

Benefit-risk analysis is required when residual risk remains high after controls, no feasible risk reduction exists, the device is novel, or an unacceptable risk is offset by clinical benefit. It is not required when all risks are low.

What triggers a risk management file update after product launch?▼

Updates are triggered by serious incidents (immediate review), newly identified hazards (30 days), adverse trend increases (60 days), design changes, and standards updates. Information sources include complaints, service reports, vigilance data, and literature monitoring.

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