| name | udi-labeling-generator |
| description | Unique Device Identification (UDI) and labeling compliance skill for generating compliant labels and device identifiers |
| allowed-tools | ["Read","Write","Glob","Grep","Edit","Bash"] |
| metadata | {"specialization":"biomedical-engineering","domain":"science","category":"Regulatory Compliance","skill-id":"BME-SK-004"} |
| graph | {"domains":["domain:biomedical-engineering"],"skillAreas":["skill-area:data-analysis","skill-area:compliance-automation","skill-area:python-data-pipelines"],"workflows":["workflow:experiment-design","workflow:peer-review-cycle"],"roles":["role:biomedical-engineer","role:compliance-engineer"]} |
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
