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Using obsolete or incorrect symbols (e.g., from outdated ISO 15223-1 versions) leading to reviewer questions or outright rejection in the EU.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.
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.
関連リソース
UDI Implementation Guide for Korea and Global Markets
Korea's UDI system runs on Korean GS1 codes and ties to the MFDS database. A practical implementation guide aligned with FDA UDI and EU MDR EUDAMED requirements.
2026.06.02
Lean Documentation Principles for IFUs and Labeling
Most medical device IFUs are bloated, ambiguous, and translation-hostile. Lean documentation principles cut size by 40% while improving regulatory robustness.
2026.05.27
Building Launch Marketing Assets That Pass MFDS Review
Korean medical device advertising regulations are stricter than FDA promotional rules. A guide for marketing teams launching imported devices in Korea.
2026.05.30
Print with Confidence.
Ensure your labels are compliant, scannable, and accurate across every market, every time.
Audit My Labeling Strategy