Is it suitable for FDA or CE mark documentation?

Yes, it provides the structured frameworks and templates required to build a Risk Management File (RMF) suitable for global regulatory submissions.

Can it help with post-market surveillance?

Yes, it includes specific workflows for post-production information analysis, incident response, and periodic risk management reviews.

Does this skill follow ISO 14971:2019 standards?

Yes, the skill is specifically designed to implement risk management processes aligned with the ISO 14971:2019 international standard for medical devices.

What analysis methods are supported?

It supports multiple methodologies including FMEA (Failure Mode and Effects Analysis), FTA (Fault Tree Analysis), HAZOP, and Use Error Analysis.

Medical Device Risk Management Specialist

Name: Medical Device Risk Management Specialist
Author: borghei

byborghei

•

Security & Testing

Implements ISO 14971 risk management protocols throughout the medical device lifecycle using standardized analysis and control workflows.

This skill transforms Claude into an ISO 14971-compliant specialist for medical device risk management. It provides comprehensive workflows for risk analysis (FMEA, FTA), evaluation using 5x5 matrices, and the implementation of risk controls according to the safety hierarchy. Ideal for quality assurance and regulatory affairs teams, it facilitates hazard identification, benefit-risk analysis, and post-production monitoring to ensure device safety and regulatory compliance during the development and maintenance of medical hardware and software.

Key Features

01Automated 5x5 risk acceptability matrix and evaluation logic

02Standardized risk control hierarchy and verification templates

03Post-market surveillance and risk monitoring workflows

0450 GitHub stars

05Multi-method risk analysis including FMEA, FTA, and HAZOP

06ISO 14971:2019 compliant risk management planning and documentation

Use Cases

01Establishing a Risk Management Plan (RMP) for regulatory submission (FDA/CE)

02Evaluating residual risks and performing benefit-risk analysis for novel medical technologies

03Conducting a Failure Mode and Effects Analysis (FMEA) for a new medical device component

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add borghei/claude-skills risk-management-specialist

For use in Claude.ai and ChatGPT

Download Skill