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udi-labeling-generator

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Unique Device Identification (UDI) and labeling compliance skill for generating compliant labels and device identifiers

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Source SKILL.md: https://github.com/a5c-ai/babysitter/blob/HEAD/library/specializations/domains/science/biomedical-engineering/skills/udi-labeling-generator/SKILL.md

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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
  • EUDAMED system
  • ISO 15223-1 symbol library
  • Issuing agency interfaces

Configuration

udi-labeling-generator:
  issuing-agencies:
    - GS1
    - HIBCC
    - ICCBBA
  label-types:
    - device-label
    - package-label
    - shipping-label
  barcode-formats:
    - GS1-128
    - DataMatrix
    - QR-Code
  regulatory-regions:
    - FDA
    - EU-MDR
    - Health-Canada

Output Artifacts

  • UDI-DI assignments
  • UDI-PI format specifications
  • GUDID submission files
  • Label content templates
  • IFU drafts
  • Barcode specifications
  • Symbol usage guides
  • Multi-language label sets

Quality Criteria

  • UDI format complies with issuing agency requirements
  • Labels meet FDA 21 CFR 801 requirements
  • EU MDR Annex VI requirements satisfied
  • Symbols conform to ISO 15223-1
  • Barcodes meet readability specifications
  • Package hierarchy accurately represented