Risk Management Specialist
Medical device risk management specialist implementing ISO 14971 throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis. Use when user mentions risk management, ISO 14971, risk analysis, FMEA, fault tree analysis, hazard identification, risk control, risk matrix, benefit-risk analysis, residual risk, risk acceptability, or post-market risk.
Install
npx skills add chenxihuang1028-a11y/risk-management-specialist --skill risk-management-specialistgit clone --depth 1 https://github.com/chenxihuang1028-a11y/risk-management-specialist.git /tmp/risk-management-specialist
mkdir -p ~/.claude/skills
cp -r /tmp/risk-management-specialist/. ~/.claude/skills/risk-management-specialistPersonal skills live in ~/.claude/skills. Use .claude/skills in a project folder to share a skill with your team.
From the SKILL.md
# Risk Management Specialist ISO 14971:2019 risk management implementation throughout the medical device lifecycle. > **Use boundary:** The bundled matrix and RPN thresholds are illustrative > defaults, not values mandated by ISO 14971. A qualified risk owner must define > and approve device-specific acceptability criteria, verify control > effectiveness, and approve regulated records. The skill supports analysis and > drafting; it does not certify compliance or replace clinical, engineering, or > regulatory judgment. --- ## 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) - [Decision Frameworks](#decision-frameworks) - [Tools and References](#tools-and-references) --- ## Risk Management Planning Workflow Establish risk management process per ISO 14971. ### Workflow: Create Risk Management Plan 1. Define scope of risk management activities: - Medical device identification - Lifecycle stages covered - Applicable standards and regulations 2. Establish risk acceptability criteria: - Define probability categories (P1-P5) - Define severity categories (S1-S5) - Create risk matrix with acceptance thresholds
Details
- Skill name
risk-management-specialist- License
- MIT
- Repo updated
- 28 July 2026
FAQ
What does the Risk Management Specialist skill do?
Medical device risk management specialist implementing ISO 14971 throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis. Use when user mentions risk management, ISO 14971, risk analysis, FMEA, fault tree analysis, hazard identification, risk control, risk matrix, benefit-risk analysis, residual risk, risk acceptability, or post-market risk.
How do I install the Risk Management Specialist skill?
skills CLI (Claude Code, Cursor, Codex and more): npx skills add chenxihuang1028-a11y/risk-management-specialist --skill risk-management-specialist. Skills go in ~/.claude/skills (personal) or .claude/skills (project), and Claude loads them automatically when a task matches the description.
Is Risk Management Specialist popular?
It lives in chenxihuang1028-a11y/risk-management-specialist, which has 6 GitHub stars and 0 forks.
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