risk-management-specialist

Name: risk-management-specialist
Availability: InStock
Author: tapanshah

Implements ISO 14971:2019 workflows for medical device risk management and compliance.

Updated Mar 7, 2026

Search Tags:#compliance #risk management #medical device #FMEA #hazard analysis #ISO 14971

Ready to run

npx skills add https://github.com/tapanshah/Claude-Skills --skill risk-management-specialist-tapanshah

💬 Prompt for ChatGPT / Claude Chat▼

Please help me install this Agent Skill.
Skill: risk-management-specialist
Source: https://github.com/tapanshah/Claude-Skills/tree/main/ra-qm-team/risk-management-specialist
Command: npx skills add https://github.com/tapanshah/Claude-Skills --skill risk-management-specialist-tapanshah

SYSTEM DOCUMENTATION & REQUIREMENTS

💡 This Skill 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 all phases of risk management, from planning to post-production monitoring.
Risk Analysis & Control: Offers detailed workflows for hazard identification, risk estimation, and the implementation of control measures using a defined hierarchy.
Use Case: A startup developing a new medical device can use this Skill to establish a robust risk management process, generate necessary documentation, and ensure regulatory compliance from the outset.

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 14971:2019 for medical device risk management?▼

To implement ISO 14971:2019 for medical device risk management, you follow a structured process covering planning, analysis, evaluation, control, and post-production activities to ensure device safety and regulatory compliance.

What is the best way to perform FMEA and hazard analysis for medical devices?▼

The best way to perform FMEA and hazard analysis for medical devices is to use structured workflows that guide hazard identification, risk estimation, and the application of a defined risk control hierarchy.

How do I create a risk management plan for a new medical device startup?▼

To create a risk management plan for a new medical device startup, establish a robust process from the outset that includes hazard identification, risk matrix application, and benefit-risk analysis documentation.

When do I need a benefit-risk analysis for medical device compliance?▼

You need a benefit-risk analysis for medical device compliance when evaluating residual risks during the ISO 14971 risk management process to ensure the device's overall benefits outweigh its potential hazards.

Can I use this risk management framework for post-production monitoring of medical devices?▼

Yes, you can use this ISO 14971 risk management framework for post-production monitoring of medical devices to systematically identify, evaluate, and control newly discovered risks throughout the device lifecycle.