risk-management-specialist

Implement ISO 14971:2019 workflows for medical device risk management.

2|Updated Mar 13, 2026

Search Tags:#compliance #risk management #medical device #iso 14971 #hazard analysis #fmea

Ready to run

npx skills add https://github.com/zhangzhang-111-i/claude-skills111 --skill risk-management-specialist-zhangzhang-111-i

💬 Prompt for ChatGPT / Claude Chat▼

Please help me install this Agent Skill.
Skill: risk-management-specialist
Source: https://github.com/zhangzhang-111-i/claude-skills111/tree/main/ra-qm-team/risk-management-specialist
Command: npx skills add https://github.com/zhangzhang-111-i/claude-skills111 --skill risk-management-specialist-zhangzhang-111-i

SYSTEM DOCUMENTATION & REQUIREMENTS

💡 This Skill requires risk_matrix_calculator.py, and includes scripts (resource) and references (resource) components.

What problem does it solve?

This Skill provides a comprehensive framework for implementing ISO 14971:2019, ensuring medical devices are safe and effective throughout their lifecycle by systematically identifying, evaluating, and controlling risks.

Core Features & Use Cases

ISO 14971 Compliance: Guides users through risk management planning, analysis, evaluation, and control.
Risk Assessment Tools: Includes templates and workflows for FMEA, FTA, and hazard analysis.
Post-Production Monitoring: Establishes procedures for ongoing risk management after market release.
Use Case: A medical device startup needs to create a robust Risk Management File for their new product. This Skill guides them through each step, from defining the risk acceptability criteria to setting up post-market surveillance.

Quick Start

Use the risk-management-specialist skill to generate a risk management plan for a new infusion pump.

Frequently Asked Questions about risk-management-specialist

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

FAQPage Schema

How do I implement ISO 14971 risk management for a medical device?▼

ISO 14971 risk management is implemented by following structured workflows for risk analysis, evaluation, control, and post-production monitoring. This ensures medical devices are systematically evaluated for safety and compliance throughout their entire product lifecycle.

What is the best way to create a medical device Risk Management File?▼

Creating a medical device Risk Management File is best achieved by defining risk acceptability criteria and documenting hazard analysis. This framework guides you from initial risk evaluation to establishing ongoing post-market surveillance procedures.

Can I use FMEA and FTA templates for medical device hazard analysis?▼

FMEA and FTA templates are explicitly supported for medical device hazard analysis. The framework provides structured workflows to identify, evaluate, and control risks, ensuring your assessment aligns with international safety standards.

Does this ISO 14971 framework cover post-market surveillance for medical devices?▼

The ISO 14971 framework covers post-market surveillance by establishing procedures for ongoing risk management. This post-production monitoring ensures continued compliance and device safety after the medical device is released to market.

How do I set up a risk management plan for a new medical device?▼

Setting up a risk management plan involves defining the scope and risk acceptability criteria for your medical device. You then execute risk analysis, evaluation, and control workflows to ensure comprehensive safety and compliance documentation.