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.
Profile →npx skills add alirezarezvani/claude-skills --skill risk-management-specialist --agent claude-code
Same command for any agent — swap --agent for codex, cursor, copilot.
Weekly change comes from our own snapshots, not the repository page — it measures attention, not adoption.
# Risk Management Specialist ISO 14971:2019 risk management implementation throughout the medical device lifecycle. --- ## 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 3. Assign responsibilities: - Risk management lead - Subject matter experts - Approval authorities 4. Define verification activities: - Methods for control verif
- Table of Contents
- Risk Management Planning Workflow
- Workflow: Create Risk Management Plan
- Risk Management Plan Content
- Risk Acceptability Matrix (5x5)
- Risk Level Actions
- Risk Analysis Workflow
- Workflow: Conduct Risk Analysis
- Hazard Categories Checklist
- Analysis Method Selection
- Probability Criteria
- Severity Criteria
- Risk Evaluation Workflow
- Workflow: Evaluate Identified Risks
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 it?
Run `npx skills add alirezarezvani/claude-skills --skill risk-management-specialist --agent claude-code` — it drops the skill into your project so the agent can pick it up. Swap the --agent value for codex, cursor or copilot if you use one of those.
Where does this skill come from?
From alirezarezvani/claude-skills, a repository with 23,791 stars. We read it straight from the repository tree rather than a submitted listing, so what you see here is what is actually published.
Is a popular skill a good skill?
Not necessarily. Stars measure attention, not adoption — a repository can trend for a week and be abandoned. That is why we show the weekly change from our own snapshots next to the total, instead of a single flattering number.