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domain-healthcare:medical-device-software

Guide medical device software development through IEC 62304 and ISO 14971 compliance.

14|3|Updated Feb 22, 2026
Search Tags:#software development#cybersecurity#regulatory compliance#medical device#FDA#IEC 62304#ISO 14971
One-click install
npx skills add https://github.com/rnavarych/alpha-engineer --skill domain-healthcare-medical-device-software
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: domain-healthcare:medical-device-software
Source: https://github.com/rnavarych/alpha-engineer/tree/main/plugins/domains/domain-healthcare/skills/medical-device-software
Command: npx skills add https://github.com/rnavarych/alpha-engineer --skill domain-healthcare-medical-device-software

SYSTEM DOCUMENTATION & REQUIREMENTS

💡 This Skill includes references (resource) components.

What problem does it solve?

This Skill provides comprehensive guidance and structured information for developing medical device software in compliance with stringent regulatory standards like IEC 62304 and ISO 14971, ensuring safety and market readiness.

Core Features & Use Cases

  • Regulatory Compliance: Understand and apply IEC 62304 software lifecycle processes and ISO 14971 risk management.
  • Documentation Planning: Identify essential documentation for regulated software projects, including SDP, SRS, SAD, and traceability matrices.
  • Risk Management: Perform hazard analysis, build risk management files, and apply the risk control hierarchy.
  • Design Controls: Structure design inputs, outputs, verification, and validation for FDA submissions (510(k), PMA, De Novo).
  • Cybersecurity: Address FDA premarket cybersecurity guidance, including SBOM generation and vulnerability management.
  • Use Case: A startup developing a new Class B medical device needs to understand the required documentation and risk management activities for their software. This Skill provides the framework and references to guide them through the process.

Quick Start

Explain the software safety classification process according to IEC 62304.

Frequently Asked Questions about domain-healthcare:medical-device-software

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

FAQPage Schema
How do I determine the software safety classification for a medical device according to IEC 62304?▼

IEC 62304 software safety classification is determined by the potential to cause death or injury. Class A cannot contribute to a hazardous situation, Class B could cause non-serious injury, and Class C could cause death or serious injury.

What documentation is required for FDA premarket submissions of medical device software?▼

FDA premarket submissions require a Software Development Plan, Software Requirements Specification, Software Architecture Design, and traceability matrices. Verification and validation documentation must demonstrate adherence to design controls.

How to perform hazard analysis and risk assessment for medical device software using ISO 14971?▼

ISO 14971 risk assessment involves identifying device hazards, estimating severity and probability, evaluating risk acceptability, implementing risk control measures, and maintaining a comprehensive risk management file.

Does my Class B medical device software require a cybersecurity vulnerability management plan for FDA submission?▼

Class B medical device software requires cybersecurity vulnerability management for FDA submission. Premarket submissions must address cybersecurity guidance including SBOM generation and vulnerability monitoring.

What is the best way to structure V&V activities for IEC 62304 compliant medical device software?▼

The best way to structure V&V activities is by mapping software requirements to test cases using a traceability matrix. This ensures software verification confirms design outputs meet inputs, and validation confirms user needs.

When do I need to apply design controls to medical device software development?▼

Design controls must be applied throughout the entire software development lifecycle to ensure regulatory compliance. They govern design inputs, outputs, verification, and validation activities required for market readiness.

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