ReddRadar
Agent skill
udi-labeling-generator
Unique Device Identification (UDI) and labeling compliance skill for generating compliant labels and device identifiers
Install this agent skill to your Project
npx add-skill https://github.com/a5c-ai/babysitter/tree/main/library/specializations/domains/science/biomedical-engineering/skills/udi-labeling-generator
Metadata
Additional technical details for this skill
- domain
- science
- category
- Regulatory Compliance
- skill id
- BME-SK-004
- specialization
- biomedical-engineering
SKILL.md
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
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