Global Labeling & UDI Implementation

Zero Errors. Global Compliance. Patient Safety.

The High Cost of a Typo

In MedTech, a labeling error isn't just a typo; it's a recall event, a supply chain failure, and a potential risk to patient safety.

UDI Mismatches

Barcodes that don't scan or data that doesn't match FDA GUDID or EUDAMED databases, causing costly supply chain disruptions.

Symbol Confusion

Using obsolete or incorrect symbols (e.g., from outdated ISO 15223-1 versions) leading to reviewer questions or outright rejection in the EU.

Translation Rework

Inconsistent source terminology that leads to expensive and time-consuming rework loops with translation vendors across multiple markets.

The Leanabl Insight

We treat Labeling as a 'Process', not just 'Graphic Design'. A robust labeling system is a core manufacturing process that requires rigorous version control, data validation, and quality oversight—just like any other part of your device.

End-to-End Labeling Lifecycle Management

We execute specific labeling projects or manage your entire global labeling system, ensuring accuracy from data source to final print.

UDI & Database Management

We handle GTIN/HIBC generation and data entry for global databases, including FDA GUDID, EUDAMED, and the Korean UDI system.

Content & Symbol Strategy

We ensure full compliance with ISO 15223-1, create master labeling documents, and manage efficient translation workflows.

Artwork Design & Engineering

Our team creates print-ready Adobe Illustrator files, optimized for legibility and manufacturability, even on small or complex device surfaces.

A compliant medical device label with callouts showing UDI barcodes and symbols.

From Data to Print

Content Definition

We verify every piece of information against the Design History File (DHF) to ensure accuracy from the start.

Design & UDI

We create compliant artwork and register all necessary Unique Device Identification data with global authorities.

Validation & Proof

A multi-stage proofreading and verification process ensures what's printed is what was approved.

Your Complete Labeling Package

Print-Ready Artwork

UDI Data Sets

Labeling Specifications

Why Trust Us with Your Labels?

Korea UDI Expertise
We specialize in the nuances of barcode encoding and database registration required by Korea's Ministry of Food and Drug Safety (MFDS).
Integration with eIFU
We seamlessly link your physical device labels to our electronic Instructions for Use platform (LeanIFU), ensuring a single source of truth.
Recall Prevention
Our rigorous Labeling Verification process acts as a final firewall, catching errors that are often missed by internal teams and preventing costly recalls.