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Babysitter udi-labeling-generator

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

install
source · Clone the upstream repo
git clone https://github.com/a5c-ai/babysitter
Claude Code · Install into ~/.claude/skills/
T=$(mktemp -d) && git clone --depth=1 https://github.com/a5c-ai/babysitter "$T" && mkdir -p ~/.claude/skills && cp -r "$T/library/specializations/domains/science/biomedical-engineering/skills/udi-labeling-generator" ~/.claude/skills/a5c-ai-babysitter-udi-labeling-generator && rm -rf "$T"
manifest: library/specializations/domains/science/biomedical-engineering/skills/udi-labeling-generator/SKILL.md
tags
#udi-generation#regulatory-compliance#labeling#gudid#eudamed#medical-devices
source content

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