risk-management-specialist

Name: risk-management-specialist
Availability: InStock
Author: i-onlabs

Identifies and manages ISO 14971-compliant risk across the medical device lifecycle.

3|1|Updated Dec 21, 2025

Search Tags:#risk-management #risk-evaluation #medical-device #hazard-identification #iso14971 #post-market

Ready to run

npx skills add https://github.com/I-Onlabs/claude-code-skills --skill risk-management-specialist-i-onlabs

💬 Prompt for ChatGPT / Claude Chat▼

Please help me install this Agent Skill.
Skill: risk-management-specialist
Source: https://github.com/I-Onlabs/claude-code-skills/tree/main/risk-management-specialist
Command: npx skills add https://github.com/I-Onlabs/claude-code-skills --skill risk-management-specialist-i-onlabs

SYSTEM DOCUMENTATION & REQUIREMENTS

💡 This Skill includes scripts (resource) and references (resource) and assets (resource) components.

What problem does it solve?

Senior Risk Management specialist for medical device companies implementing ISO 14971 risk management throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis. Use for risk management planning, risk assessments, risk control verification, and risk management file maintenance.

Core Features & Use Cases

Risk management process implementation (ISO 14971)
Risk analysis and hazard identification
Risk evaluation and risk control verification
Software risk management integration (IEC 62304)
Cybersecurity risk management
Post-production information management

Quick Start

Initiate ISO 14971-based risk management planning and implement ongoing risk analysis, control, and post-market monitoring.

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 across a medical device lifecycle?▼

ISO 14971 risk management implementation covers risk planning, analysis, evaluation, control, and post-production information across hardware, software, cybersecurity, and use-related risks. It satisfies functional requirements for risk management file maintenance within a regulated framework.

What is hazard identification and risk estimation for medical devices?▼

Hazard identification and risk estimation are core phases of ISO 14971 risk analysis. They involve identifying potential hazards, estimating associated risks, and applying methodology to ensure compliant medical device safety evaluation throughout the product lifecycle.

Can I integrate IEC 62304 software risk management with ISO 14971 processes?▼

Yes, ISO 14971 risk management processes support integration with IEC 62304 software risk management. The methodology applies hazard identification, risk evaluation, and control verification across hardware and software components within a unified regulated framework.

How do I manage post-production information for medical device risk files?▼

Post-production information management involves ongoing monitoring and analysis of post-market data to maintain the risk management file. It updates risk evaluation and control verification based on real-world hardware, software, and cybersecurity information.

Does this risk evaluation methodology cover cybersecurity and use-related risks?▼

Yes, the risk evaluation methodology explicitly addresses cybersecurity and use-related risks alongside hardware and software hazards. It applies ISO 14971–compliant hazard identification and risk control across all these domains for comprehensive medical device safety.

What do I need to verify risk controls for a medical device risk management plan?▼

Risk control verification requires applying the ISO 14971 methodology to ensure implemented controls effectively reduce identified hazards. It validates risk estimation and satisfies regulated risk management plan requirements for hardware, software, and cybersecurity risks.