risk-management-specialist

Implement ISO 14971:2019 workflows for medical device risk management.

Updated Mar 4, 2026

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

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npx skills add https://github.com/Tonybleything76/more-claude-skills --skill risk-management-specialist-tonybleything76

💬 Prompt for ChatGPT / Claude Chat▼

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Skill: risk-management-specialist
Source: https://github.com/Tonybleything76/more-claude-skills/tree/main/ra-qm-team/risk-management-specialist
Command: npx skills add https://github.com/Tonybleything76/more-claude-skills --skill risk-management-specialist-tonybleything76

SYSTEM DOCUMENTATION & REQUIREMENTS

💡 This Skill requires pypdf, pdfplumber, pdf2image, and 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 meet stringent risk management requirements throughout their lifecycle.

Core Features & Use Cases

End-to-End Risk Management: Covers planning, analysis, evaluation, control, and post-production monitoring.
Standardized Compliance: Adheres strictly to ISO 14971 guidelines for regulatory approval.
Use Case: A startup developing a new Class II medical device can use this Skill to establish a robust risk management process from day one, ensuring compliance and patient safety.

Quick Start

Initiate the risk management planning workflow for a new medical device by defining its scope and acceptability criteria.

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 risk management for a new medical device?▼

Implement ISO 14971 risk management by initiating the planning workflow to define device scope and acceptability criteria, followed by hazard analysis, risk evaluation, control selection, and post-production monitoring.

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

The best way to conduct FMEA and hazard analysis is using standardized workflows that identify device hazards, evaluate risks, and select controls to ensure regulatory compliance and patient safety.

Do I need to define acceptability criteria before starting ISO 14971 risk planning?▼

Yes, you need to define acceptability criteria during the initial risk management planning phase to establish the scope and thresholds for evaluating medical device risks.

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

Yes, you can use this framework for post-production risk monitoring as it covers end-to-end lifecycle activities including post-production evaluation for medical devices.

Does this ISO 14971 workflow support benefit-risk analysis for regulatory approval?▼

Yes, this workflow supports benefit-risk analysis by providing structured evaluation and control selection processes to ensure medical devices meet stringent regulatory approval requirements.

Why is ISO 14971 compliance necessary for Class II medical device development?▼

ISO 14971 compliance is necessary for Class II medical device development to establish a robust risk management process that ensures patient safety and meets regulatory requirements throughout the lifecycle.