Udi labeling generator

Skill a5c-ai/babysitter/library/specializations/domains/science/biomedical-engineering/skills/udi-labeling-generator

Unique Device Identification (UDI) and labeling compliance skill for generating compliant labels and device identifiersFrom its SKILL.md

Install

npx -y skills add a5c-ai/babysitter --skill udi-labeling-generator

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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

What ships with it

Read from the repository

Just SKILL.md. No reference files, no scripts.