medical-device-software-compliance

Provide regulatory decision frameworks for SaMD compliance across FDA and EU MDR.

13|5|Updated May 4, 2026

Search Tags:#compliance #risk-management #fda #regulatory #iec-62304 #samd

Ready to run

npx skills add https://github.com/awslabs/hcls-agent-skills --skill medical-device-software-compliance

💬 Prompt for ChatGPT / Claude Chat▼

Please help me install this Agent Skill.
Skill: medical-device-software-compliance
Source: https://github.com/awslabs/hcls-agent-skills/tree/main/skills/medical-device-software-compliance
Command: npx skills add https://github.com/awslabs/hcls-agent-skills --skill medical-device-software-compliance

SYSTEM DOCUMENTATION & REQUIREMENTS

What problem does it solve?

This skill resolves the complexity of navigating global medical device software regulations, ensuring that development teams meet stringent safety and documentation requirements without stalling innovation.

Core Features & Use Cases

Regulatory Decision Support: Provides expert guidance on FDA 510(k), De Novo, and PMA pathways, as well as EU MDR compliance.
Lifecycle Management: Maps software development phases to IEC 62304 and 21 CFR 820.30 standards, including risk management and design controls.
Use Case: Use this skill to determine the safety classification of a new AI-based diagnostic tool, generate a compliant traceability matrix, or assess the risk profile of third-party software components (SOUP).

Quick Start

Invoke the medical-device-software-compliance skill to evaluate the regulatory pathway and documentation requirements for a new Class II software as a medical device.

Frequently Asked Questions about medical-device-software-compliance

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

FAQPage Schema

How do I determine the IEC 62304 safety classification for my medical device software?▼

IEC 62304 safety classification requires evaluating potential harm to patients and users. This skill provides expert reasoning frameworks to classify your Software as a Medical Device accurately, mapping the classification to necessary lifecycle documentation and design controls required for compliance.

What is the regulatory pathway for an AI-based diagnostic tool under FDA and EU MDR?▼

The regulatory pathway for an AI-based diagnostic tool depends on its risk profile and intended use. This skill guides you through FDA 510(k), De Novo, PMA, and EU MDR compliance requirements, helping you determine the correct submission strategy and necessary documentation.

How do I generate a compliant traceability matrix for Software as a Medical Device?▼

Generating a compliant traceability matrix involves linking software requirements, design specifications, risk controls, and verification activities. This skill maps your software development phases to 21 CFR 820.30 design controls and IEC 62304 standards to ensure formal traceability throughout the lifecycle.

How do I assess the risk profile of third-party software components (SOUP) for medical software compliance?▼

Assessing SOUP risk involves identifying anomalies, hazards, and cybersecurity vulnerabilities in third-party components. This skill supports ISO 14971 risk management by providing decision frameworks to evaluate third-party software components and integrate them safely into your medical device system.

Can I use this skill to map software development phases to 21 CFR 820 design controls?▼

Yes, this skill maps software development phases directly to 21 CFR 820.30 and IEC 62304 lifecycle requirements. It provides structured reasoning to ensure your design inputs, outputs, reviews, and validation activities satisfy formal regulatory documentation standards.

Does this skill support cybersecurity assessment requirements for medical device software?▼

Yes, this skill satisfies requirements for cybersecurity assessment in medical software development. It provides expert reasoning to evaluate security risks alongside ISO 14971 risk management, ensuring your SaMD meets FDA and EU MDR cybersecurity documentation expectations.