ISO 14971 Risk Management for Software
CommunityIntegrate ISO 14971 risk management.
Legal & Compliance#software development#compliance#risk management#medical device#iso 14971#hazard analysis#risk control
AuthorAminAlam
Version1.0.0
Installs0
System Documentation
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.
Dependency Matrix
Required Modules
None requiredComponents
references
💻 Claude Code Installation
Recommended: Let Claude install automatically. Simply copy and paste the text below to Claude Code.
Please help me install this Skill: Name: ISO 14971 Risk Management for Software Download link: https://github.com/AminAlam/meddev-agent-skills/archive/main.zip#iso-14971-risk-management-for-software Please download this .zip file, extract it, and install it in the .claude/skills/ directory.
Agent Skills Search Helper
Install a tiny helper to your Agent, search and equip skill from 223,000+ vetted skills library on demand.