risk-management-specialist

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

Automate ISO 14971 risk management workflows for medical devices.

Updated Dec 23, 2024

Search Tags:#compliance #risk-management #regulatory #risk-analysis #FMEA #medical-device #ISO14971

Ready to run

npx skills add https://github.com/salamientark/dotfiles --skill risk-management-specialist-salamientark

💬 Prompt for ChatGPT / Claude Chat▼

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

SYSTEM DOCUMENTATION & REQUIREMENTS

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

What problem does it solve?

ISO 14971 risk management is applied across the full medical device lifecycle, enabling structured planning, analysis, and documentation to manage risk.

Core Features & Use Cases

ISO 14971-aligned risk management workflow templates (planning, analysis, evaluation, control, post-production).
Hazard identification, risk analysis, FMEA/FTA/HAZOP workflows, and post-market information integration.
Practical use case: generate a complete RM file with templates and reference materials for a medical device project.

Quick Start

Initiate a risk management workflow for a medical device by generating a complete RM file and sample worksheets.

Frequently Asked Questions about risk-management-specialist

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

FAQPage Schema

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

You can automate ISO 14971 risk management by generating a complete RM file with structured templates and a Python risk calculator. This workflow covers planning, hazard analysis, evaluation, control, and post-market surveillance across the device lifecycle.

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

The best way to conduct FMEA and hazard analysis is using structured RM worksheets aligned with ISO 14971. These templates support FMEA, FTA, and HAZOP workflows while integrating post-market information to quantify risk levels accurately.

Can I use a Python risk calculator to quantify medical device risk levels?▼

Yes, you can use the included Python risk calculator script to quantify medical device risk levels. It supports FMEA, FTA, and HAZOP analyses by calculating risk priorities to support your ISO 14971 compliance documentation.

Does ISO 14971 risk management cover post-market surveillance for medical devices?▼

Yes, ISO 14971 risk management covers post-market surveillance for medical devices. The workflow integrates post-production information and post-market surveillance into the overall risk management file to ensure ongoing compliance.

Do I need prior regulatory compliance experience to generate a medical device RM file?▼

You do not need extensive prior regulatory experience to generate a medical device RM file. The workflow provides structured templates and reference materials guiding you through ISO 14971 risk planning, analysis, and control processes.