Does this skill provide legal regulatory citations?

Yes, for detailed analysis levels, the skill provides specific citations such as 21 CFR sections, EU MDR Articles, and MFDS legal clauses.

How does it handle software or digital health apps?

It uses a specific 4-Gate Analysis framework to evaluate digital technologies like AI, IoT, and VR to determine if they meet the criteria for digital medical devices.

Which regulatory regions does this skill support?

The skill currently supports the United States (FDA 21 CFR), the European Union (EU MDR 2017/745), and South Korea (MFDS Medical Device Act).

What happens if a product is in a regulatory 'grey area'?

The skill will return a 'CONDITIONAL' status, triggering a specific output contract that identifies the uncertainty basis and the specific conditions needed to resolve the status.

Medical Device Regulatory Determination

Name: Medical Device Regulatory Determination
Author: henry-1981

byhenry-1981

0•

Productivity & Workflow

Evaluates product specifications against FDA, EU MDR, and MFDS regulations to determine official medical device status and regulatory scope.

The Aria Determination skill is a specialized tool for Regulatory Affairs (RA) professionals and medical device developers. It automates the complex task of evaluating whether a product qualifies as a medical device across three major jurisdictions: the US (FDA 21 CFR), Europe (EU MDR), and South Korea (MFDS). By analyzing intended use, mechanism of action, and product form, it provides a structured determination result (YES/NO/CONDITIONAL) complete with regulatory citations, traffic-light risk assessments, and a mandatory 4-Gate analysis for digital health products.

Key Features

010 GitHub stars

02Mandatory 4-Gate Decision Logic for software and digital health products.

03Multi-jurisdiction analysis for FDA (US), EU MDR (EU), and MFDS (KR) standards.

04Detection of borderline cases, wellness products, and combination drug-device products.

05Structured output including regulatory citations and confidence-based escalation levels.

06Progressive disclosure levels providing everything from quick summaries to deep legal analysis.

Use Cases

01Identifying the regulatory boundary between general wellness products and regulated medical devices.

02Determining if a health-focused software application qualifies as Software as a Medical Device (SaMD).

03Generating preliminary regulatory evidence and citations for international market entry strategies.

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add henry-1981/cowork-ra determination

For use in Claude.ai and ChatGPT

Download Skill