risk-management-specialist

Implement ISO 14971 risk management workflows for medical devices.

Updated Mar 12, 2026

Search Tags:#compliance #risk management #medical device #iso 14971 #fmea #fta #alarp

Ready to run

npx skills add https://github.com/Fantasia1999/claude-skills-zh --skill risk-management-specialist-fantasia1999

💬 Prompt for ChatGPT / Claude Chat▼

Please help me install this Agent Skill.
Skill: risk-management-specialist
Source: https://github.com/Fantasia1999/claude-skills-zh/tree/main/translations/ra-qm-team/risk-management-specialist
Command: npx skills add https://github.com/Fantasia1999/claude-skills-zh --skill risk-management-specialist-fantasia1999

SYSTEM DOCUMENTATION & REQUIREMENTS

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

What problem does it solve?

This Skill helps medical device manufacturers implement ISO 14971, ensuring product safety throughout the entire lifecycle and meeting regulatory compliance.

Core Features & Use Cases

Comprehensive Risk Management: Covers planning, analysis, evaluation, control, and post-market surveillance according to ISO 14971:2019.
Workflow Guidance: Provides step-by-step processes for each stage of risk management.
Use Case: A new medical device company needs to establish its risk management process. This Skill guides them through creating a Risk Management Plan, performing FMEA and FTA, implementing controls, and setting up post-market monitoring.

Quick Start

Use the risk-management-specialist skill to create 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 for medical device risk management?▼

Medical device risk management under ISO 14971 involves planning, analysis, evaluation, control, and post-market surveillance. It provides structured workflows to identify hazards, assess probability and severity, implement controls, and apply ALARP principles throughout the product lifecycle.

How do I perform FMEA and FTA for medical device risk analysis?▼

Performing FMEA and FTA for medical device risk analysis requires evaluating potential failure modes and fault tree logic to identify hazards. These techniques feed into the ISO 14971 risk evaluation stage, helping determine acceptable risk levels using probability and severity assessments.

What is the ALARP principle in medical device risk control?▼

The ALARP principle in medical device risk control dictates that risks must be reduced to As Low As Reasonably Practicable. It serves as a decision framework within ISO 14971 to evaluate whether residual risks are acceptable after implementing risk control measures.

Does this provide templates for a medical device risk management plan?▼

Yes, it provides templates and decision frameworks for creating a medical device risk management plan. These resources guide manufacturers through documenting the risk management process, defining acceptance criteria, and outlining post-market monitoring activities.

How do I set up post-market surveillance for medical device risks?▼

Setting up post-market surveillance for medical device risks involves monitoring residual risks and collecting production data after deployment. Under ISO 14971, this stage ensures continuous evaluation of risk control effectiveness and identifies newly emerging hazards during the product lifecycle.