$247 — Standard Tier

UDI Compliance Toolkit: GUDID Submission and EUDAMED Registration Templates

UDI Compliance Toolkit — UDI implementation plan, GUDID submission checklist, DI/PI assignment worksheet, EUDAMED registration guide, label verification form, and database maintenance SOP.

Get the Toolkit — $247

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What's Included

UDI Implementation Plan Template
GUDID Submission Checklist (FDA AccessGUDID)
Device Identifier and Production Identifier Assignment Worksheet
EUDAMED UDI Registration and EU MDR Article 29 Checklist
UDI Label Verification Form
UDI Database Maintenance and Annual Update SOP

Benefits

FDA GUDID and EU EUDAMED checklists in one toolkit
DI/PI assignment worksheet documents the logic auditors ask for
Label verification form catches barcode encoding errors before product ships
Database maintenance SOP keeps GUDID and EUDAMED synchronized with actual labeled product

Is This For You?

This toolkit is designed for teams facing these challenges:

GUDID submission rejected for missing or incorrect data elements
EUDAMED registration errors due to Basic UDI-DI vs UDI-DI hierarchy confusion
UDI barcode encoding errors not caught before product ships
No process for updating GUDID when device labeling changes

Who This Is For

RA managers implementing UDI compliance programsLabeling teams building UDI label verification processesQA directors integrating UDI into change control systemsGlobal manufacturers needing FDA and EU MDR UDI compliance

Frequently Asked Questions

Which devices require UDI compliance?

FDA UDI requirements apply to most US-distributed medical devices. Class III and II have been required since 2014-2016. Class I and unclassified devices had a September 2022 compliance date.

What is the difference between DI and PI?

The Device Identifier (DI) identifies the labeler and specific version or model. The Production Identifier (PI) identifies the production instance via lot number, serial number, manufacturing date, or expiration date.

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Device Labeling Requirements

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Ready to Get Started?

Download immediately after purchase. All templates are editable Word and Excel files.

Get the Toolkit — $247

7-day money-back guarantee