udi-labeling-generator

# UDI Labeling Generator Skill ## Purpose The UDI Labeling Generator Skill creates compliant Unique Device Identification labels and manages device identifier assignments for FDA GUDID and EU EUDAMED submissions. ## Capabilities - UDI-DI and UDI-PI generation - GUDID data submission preparation - Label content validation - IFU (Instructions for Use) template generation - Multi-language labeling support - Symbol compliance verification (ISO 15223-1) - Barcode generation (GS1, HIBCC, ICCBBA) - Label artwork review assistance - EUDAMED UDI registration support - Package hierarchy management - Date format standardization ## Usage Guidelines ### When to Use - Creating device labeling for regulatory submission - Registering devices in GUDID or EUDAMED - Designing label artwork and content - Validating labeling compliance ### Prerequisites - Device identification information finalized - Issuing agency account established - Package configuration defined - Regulatory requirements identified ### Best Practices - Establish UDI strategy early in development - Validate barcode readability across packaging - Ensure symbol usage meets ISO 15223-1 - Maintain consistency across label variants ## Process Integration This skill integrates with the following processes: - 510(k) Premarket Submission Preparation - EU MDR Technical Documentation - Design Control Process Implementation - Sterile Barrier System Validation ## Dependencies - FDA GUDID API - GS1 standards and databases - EUD...