aria-classification

What problem does it solve?

This Skill automates the complex and time-consuming process of determining the regulatory classification for medical devices across multiple key global jurisdictions, reducing manual effort and potential errors.

Core Features & Use Cases

• Multi-Region Classification: Determines regulatory class for FDA (USA), EU MDR (Europe), and MFDS (South Korea).
• Risk Assessment: Analyzes device characteristics to assign appropriate risk levels.
• Use Case: A startup developing a new wearable ECG monitor can use this Skill to understand its classification requirements in the US, EU, and South Korea, guiding their regulatory strategy from the outset.

Quick Start

Determine the regulatory classification for a new implantable cardiac defibrillator.