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ISO 14971 Risk Management for Software

Integrate ISO 14971:2019 risk management into software development processes.

26|6|Updated Jan 4, 2026
Search Tags:#software development#compliance#risk management#medical device#iso 14971#hazard analysis#risk control
One-click install
npx skills add https://github.com/AminAlam/meddev-agent-skills --skill iso-14971-risk-management-for-software
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: ISO 14971 Risk Management for Software
Source: https://github.com/AminAlam/meddev-agent-skills/tree/main/regulatory/iso-14971
Command: npx skills add https://github.com/AminAlam/meddev-agent-skills --skill iso-14971-risk-management-for-software

SYSTEM DOCUMENTATION & REQUIREMENTS

💡 This Skill includes references (resource) components.

What problem does it solve?

This Skill helps integrate ISO 14971 risk management principles directly into the software development lifecycle, ensuring that hazards, risks, and their controls are systematically identified, implemented, and verified.

Core Features & Use Cases

  • Hazard Identification & Risk Evaluation: Provides a structured approach to identifying software hazards and evaluating associated risks.
  • Risk Control Implementation: Guides the implementation of specific controls in code and design, with clear traceability.
  • Verification & Residual Risk: Ensures that implemented controls are verified for effectiveness and that residual risks are documented.
  • Use Case: When developing a new feature for a medical device that could potentially lead to over-infusion, this skill helps document the hazard (over-infusion), implement a control (clamp and alarm), and verify that the control functions within the specified time limits.

Quick Start

Use the ISO 14971 skill to document the risk control for over-infusion in the attached 'risk-register.yaml' file.

Frequently Asked Questions about ISO 14971 Risk Management for Software

High-intent search queries and answers about installing and using this skill.

FAQPage Schema
How do I integrate ISO 14971 risk management into software development processes?▼

Integrate ISO 14971 risk management by systematically identifying software hazards, evaluating risks, implementing traceable controls, verifying effectiveness, and documenting residual risk throughout the medical device software lifecycle.

What is the best way to document hazard analysis and risk controls for medical device software?▼

Document hazard analysis and risk controls using structured formats like a risk-register.yaml file to ensure traceability from identified hazards through implemented code controls, safe state definitions, and fault handling mechanisms.

How do I verify the effectiveness of risk controls and document residual risk for medical device compliance?▼

Verify risk control effectiveness by testing implemented controls against specified limits, such as alarm response times, and document the remaining residual risk alongside commit traceability for auditability.

Can I use this approach for software features that could cause physical harm like over-infusion in medical devices?▼

Yes, apply ISO 14971 risk management to hazardous software features by documenting the specific hazard, implementing controls like clamps and alarms, and verifying they function within specified time limits.

Does ISO 14971 software risk management require defining safe states and fault handling mechanisms?▼

ISO 14971 software risk management requires defining safe states and fault handling mechanisms to systematically control identified hazards, ensure traceable risk controls, and maintain auditability through structured documentation.

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