Is it suitable for post-market surveillance?

Yes, it includes workflows for monitoring post-production information sources like complaints, vigilance reports, and clinical data to update the risk file.

Does it provide templates for regulatory documentation?

Yes, the skill provides structured templates for Risk Management Plans, Hazard Analysis worksheets, and Risk Control Option Analysis.

Can it help with software-specific medical device risks?

Yes, it includes specific modules for software FMEA and operational hazard analysis to address software-related failure modes and use errors.

How does it handle risk acceptability?

It uses a standardized 5x5 matrix to categorize risks and applies the ALARP principle to determine if further design changes or protective measures are mandatory.

What standard does this risk management skill follow?

This skill is specifically designed to implement the ISO 14971:2019 standard for the application of risk management to medical devices.

Risk Management Specialist (Medical Devices)

Name: Risk Management Specialist (Medical Devices)
Author: zhangzhang-111-i

byzhangzhang-111-i

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생산성 및 워크플로

Implements ISO 14971:2019 risk management processes for medical device lifecycles, from hazard identification to post-market surveillance.

This skill empowers Claude to act as a specialized consultant for medical device risk management, ensuring compliance with international standards like ISO 14971. It provides structured workflows for risk analysis (FMEA, FTA), evaluation using 5x5 matrices, and the implementation of risk controls following the established hierarchy of safety. Whether you are drafting a Risk Management Plan, performing a Benefit-Risk Analysis, or setting up post-market monitoring triggers, this tool ensures rigorous documentation and adherence to safety-first design principles throughout the product development lifecycle.

주요 기능

01ALARP (As Low As Reasonably Practicable) demonstration and benefit-risk frameworks

02Hierarchical risk control implementation from inherent safety to information for safety

030 GitHub stars

04ISO 14971 compliant risk analysis workflows including FMEA, FTA, and HAZOP

05Structured 5x5 risk evaluation matrices for probability and severity estimation

06Post-production monitoring triggers and periodic risk management review planning

사용 사례

01Developing technical documentation and residual risk summaries for FDA or CE Mark submissions

02Generating a comprehensive Risk Management Plan for new Class II or III medical devices

03Conducting automated Failure Mode and Effects Analysis (FMEA) for device hardware and software

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add zhangzhang-111-i/claude-skills111 risk-management-specialist

For use in Claude.ai and ChatGPT

주요 기능

01ALARP (As Low As Reasonably Practicable) demonstration and benefit-risk frameworks

02Hierarchical risk control implementation from inherent safety to information for safety

030 GitHub stars

04ISO 14971 compliant risk analysis workflows including FMEA, FTA, and HAZOP

05Structured 5x5 risk evaluation matrices for probability and severity estimation

06Post-production monitoring triggers and periodic risk management review planning

사용 사례

01Developing technical documentation and residual risk summaries for FDA or CE Mark submissions

02Generating a comprehensive Risk Management Plan for new Class II or III medical devices

03Conducting automated Failure Mode and Effects Analysis (FMEA) for device hardware and software