aria-determination

What problem does it solve?

This Skill helps you definitively determine if a product qualifies as a medical device according to complex regulations from the FDA, EU MDR, and MFDS, saving you from costly compliance errors.

Core Features & Use Cases

• Multi-Region Regulatory Evaluation: Assesses device status against FDA, EU MDR, and MFDS criteria.
• Clear Determination Output: Provides a YES/NO/CONDITIONAL status, traffic light assessment, and applicable regulations.
• Use Case: You've developed a new wearable ECG monitor. Use this Skill to understand its regulatory classification in the US, EU, and South Korea before you begin your market entry strategy.

Quick Start

Evaluate if a new wearable ECG monitor is a medical device under FDA, EU MDR, and MFDS regulations.