Risk Management Specialist
Implements ISO 14971:2019 risk management for medical devices across the product lifecycle. Provides structured workflows for risk management planning, risk analysis, risk evaluation, risk control, and post-production monitoring, producing risk management plans, hazard analyses, risk evaluations, and risk control documentation.
✨ What it does
- Provides step-by-step workflows for risk management planning, analysis, evaluation, control, and post-production monitor
- Includes a 5x5 risk acceptability matrix with probability and severity criteria.
- Offers decision trees for risk evaluation and risk control selection.
- Emphasizes EU MDR's 'as far as possible' (AFAP) risk reduction, not ALARP.
- Provides templates for risk control option analysis and hazard categories checklist.
- Defines triggers for benefit-risk analysis and risk management file updates.
🎯 When to use it
- When creating or updating a risk management plan for a medical device.
- When performing risk analysis using methods like FMEA, FTA, or HAZOP.
- When evaluating risks against acceptability criteria and deciding on risk controls.
- When monitoring post-production information and updating the risk management file.
- When needing to demonstrate compliance with ISO 14971 and EU MDR risk reduction requirements.
🚀 How to use
Trigger by mentioning risk management, ISO 14971, risk analysis, FMEA, FTA, hazard identification, risk control, risk matrix, benefit-risk analysis, residual risk, or post-market risk. The skill expects inputs like device description, intended use, hazard categories, and risk criteria. Example prompts:
Create a risk management plan for a new infusion pump.
Perform a risk analysis using FMEA for a surgical robot.
Evaluate the risks of a pacemaker against acceptability criteria.
📄 Output: Produces risk management plans, hazard analyses, risk evaluations, risk control documentation, and post-production monitoring plans.
📦 Add this skill to Claude Code
# 1. Get the skills repo
git clone --depth 1 https://github.com/alirezarezvani/claude-skills /tmp/claude-skills
# 2. Copy this skill into your project (or ~/.claude/skills for all projects)
mkdir -p .claude/skills
cp -r /tmp/claude-skills/ra-qm-team/skills/risk-management-specialist .claude/skills/risk-management-specialistSkill source: ra-qm-team/skills/risk-management-specialist/SKILL.md
⚠️ Good to know
Requires user-provided device details and risk criteria; does not generate actual risk data or substitute for expert judgment.
❓ FAQ
What is the difference between ALARP and AFAP?
AFAP (as far as possible) is required under EU MDR and does not consider economic factors, while ALARP (as low as reasonably practicable) allows cost-benefit weighing and is not acceptable for CE-marked devices.
When is a benefit-risk analysis required?
A benefit-risk analysis is required when residual risk remains high, no feasible risk reduction exists, the device is novel, or an unacceptable risk exists with clinical benefit.
What are the three priorities in the risk control hierarchy?
The hierarchy is: 1) inherent safety by design, 2) protective measures in the device, and 3) information for safety.
🤖 Overview, features, install steps and FAQ were generated from the project's SKILL.md on Sep 4, 2026. Always check the original source before running commands.