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risk-management-specialist

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

Updated Feb 16, 2026
Search Tags:#compliance#risk management#risk assessment#medical device#FMEA#hazard analysis#ISO 14971
One-click install
npx skills add https://github.com/Nuwanda04/Ballen-Fisk --skill risk-management-specialist-nuwanda04
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: risk-management-specialist
Source: https://github.com/Nuwanda04/Ballen-Fisk/tree/main/.cursor/skills/risk-management-specialist
Command: npx skills add https://github.com/Nuwanda04/Ballen-Fisk --skill risk-management-specialist-nuwanda04

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 and tools for implementing ISO 14971:2019, ensuring medical devices are safe and effective throughout their lifecycle by systematically identifying, evaluating, and controlling risks.

Core Features & Use Cases

  • ISO 14971 Compliance: Guides users through the entire risk management process as defined by the international standard.
  • Workflow Automation: Provides structured workflows for risk planning, analysis, evaluation, and control.
  • Use Case: A medical device manufacturer can use this Skill to generate a complete Risk Management Plan, conduct FMEA analyses for new components, and document residual risks for regulatory submissions.

Quick Start

Initiate a risk management plan for a new medical device by following the steps outlined in the Risk Management Planning Workflow.

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 medical device?▼

Yes, you can conduct FMEA hazard analysis using provided templates and structured workflows. The Skill guides you through risk evaluation and control implementation to systematically assess hazards for medical device components and document residual risks for regulatory submissions.

What is included in an ISO 14971 risk management plan?▼

Yes, the Skill supports post-production monitoring as defined by ISO 14971:2019. It provides workflows to systematically monitor residual risks and ensure ongoing medical device safety and compliance after the product enters the market.

How do I document residual risks for medical device regulatory submissions?▼

Yes, the Skill supports FMEA hazard analysis using provided templates and structured workflows. It guides you through risk evaluation and control implementation to systematically assess hazards for medical device components and document residual risks for regulatory submissions.

When do I need a benefit-risk analysis for medical device compliance?▼

Yes, you can conduct FMEA hazard analysis using provided templates and structured workflows. The Skill guides you through risk evaluation and control implementation to systematically assess hazards for medical device components and document residual risks for regulatory submissions.

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