Is it useful for cybersecurity risk assessment?

Yes, it includes frameworks for cybersecurity threat modeling and identifying detective and preventive controls in line with FDA guidance.

Can I use this for human factors engineering?

Yes, the skill provides specific workflows for use-related risk analysis, identifying critical tasks, and implementing design-based risk controls for use errors.

Can this skill help with medical software safety?

Absolutely. It integrates IEC 62304 software lifecycle processes to help determine software safety classifications (Class A, B, or C) and identify software-specific hazards.

Does this skill support the latest ISO 14971 standards?

Yes, the skill is modeled after ISO 14971:2019 requirements, covering the complete risk management process from planning to post-production.

Medical Device Risk Management Specialist

Name: Medical Device Risk Management Specialist
Author: BbgnsurfTech

byBbgnsurfTech

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安全与测试

Implements comprehensive ISO 14971 risk management processes throughout the medical device product lifecycle.

This Claude Code skill serves as an expert-level consultant for medical device risk management, specifically designed to implement and maintain ISO 14971 standards. It provides a structured framework for the entire risk management lifecycle, including systematic hazard identification, risk estimation, and the implementation of safety-by-design controls. It is particularly useful for MedTech developers needing to integrate IEC 62304 software safety, cybersecurity threat modeling, and human factors engineering into their technical documentation for FDA and EU MDR regulatory submissions.

主要功能

01ISO 14971 compliant risk analysis and hazard identification frameworks

02IEC 62304 integration for medical device software risk assessment

03Automated templates for Risk Management Plans (RMP) and Reports (RMR)

048 GitHub stars

05Comprehensive cybersecurity threat modeling and risk control implementation

06Human factors engineering to identify and mitigate use-related errors

使用场景

01Integrating post-market surveillance data into existing risk-benefit evaluations

02Developing a complete Risk Management File for FDA 510(k) or EU MDR submissions

03Conducting software safety classification and fault tree analysis for connected medical devices

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add bbgnsurftech/claude-skills-collection risk-management-specialist

For use in Claude.ai and ChatGPT

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