# Labeling

> Explore medical device labeling solutions that guarantee compliance and safety. Ensure accuracy and traceability in your products.

Source: https://lso-inc.com/medical-device-labeling/

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![Labeling](https://lso-inc.com/api/media/file/UDI_Labeling_004-3.png)

FDA-Registered

Manufacturing Facility

ISO 13485

Certified Quality System

12 Cleanrooms

Class 5–8

125,000+ Sq Ft

Regulated Manufacturing

3 Facilities

CA | NH | Costa Rica

ISO 17025

Accredited Packaging Lab

![MDM-labeling\_01](https://lso-inc.com/api/media/file/MDM-labeling_01-7.jpg)

Life Science Outsourcing provides medical device labeling solutions that ensure accuracy, compliance, and traceability for regulatory approval and end-user safety.

## Regulatory-Compliant Labelingas Part of Our End-to-End Solutions

LSO provides precision labeling that integrates seamlessly into our end-to-end medical device solutions. From FDA UDI compliance to barcode tracking, we ensure accuracy, traceability, and regulatory approval—helping you bring products to market with confidence.

![UDI\_Labeling\_004](https://lso-inc.com/api/media/file/UDI_Labeling_004-3.png)

## What is Labeling?

Medical device labeling encompasses **printing, application, and verification of product information** to comply with industry regulations and ensure patient safety.

-   **UDI (Unique Device Identification) labeling**: Compliance with FDA and global regulations.
-   **Sterile & non-sterile labels**: Designed for medical-grade packaging.
-   **Barcoding & traceability**: Ensuring full product lifecycle tracking.

![Lab Technician Inspecting Medical Device Component | Life Science Outsourcing](https://lso-inc.com/api/media/file/MDM_Implant-3.jpg)

## Who Needs Labeling?

-   **Medical device manufacturers** requiring FDA-compliant labeling.
-   **Distributors & suppliers** managing traceability and inventory.

![validation.png](https://lso-inc.com/api/media/file/validation-4.png)

## How Does Labeling Work?

1.  **Label Design & Regulatory Review**: LSO collaborates with clients to design labels that meet FDA UDI regulations and international labeling standards. Each label undergoes a compliance review to ensure accuracy, readability, and durability in various environments.
2.  **Printing & Application**: Labels are produced using high-quality, medical-grade printing techniques to ensure longevity and compliance with sterilization methods. LSO offers automated and manual label application solutions to ensure precision and adherence to packaging materials.
3.  **Inspection & Verification**: Each label undergoes a rigorous quality check to ensure legibility, proper adhesion, and compliance with regulatory requirements. Verification systems include barcode scanning, durability testing, and visual inspections to prevent labeling errors.
4.  **Compliance Documentation**: LSO provides comprehensive documentation, including labeling validation reports, regulatory submission support, and traceability records to ensure full compliance with FDA, ISO, and global requirements.

![UDI\_Labeling\_003](https://lso-inc.com/api/media/file/UDI_Labeling_003-3.png)

## What standards apply?

-   **FDA UDI Rule (21 CFR 801)** – Unique Device Identification requirements.
-   **ISO 15223-1** – Labeling symbols and information.
-   **GMP labeling requirements** – Ensuring accuracy and compliance.

## Why LSO?

-   **Full regulatory compliance** with UDI and global standards.
-   **Advanced printing & verification** to prevent labeling errors.
-   **Seamless integration** with packaging and distribution services.

[Get Started with LSO](https://lso-inc.com/contact/)

## Full EtO Validation

Comprehensive packages for regulatory compliance.

![cycles.png](https://lso-inc.com/api/media/file/cycles-4.png)

## Flexible Sterilization Cycles

From fractional to full cycles with EtO residual testing.

![qualification.png](https://lso-inc.com/api/media/file/qualification-4.png)

## Robust Qualification

Secure with 2X qualification.

![pcds.png](https://lso-inc.com/api/media/file/pcds-4.png)

## Choice of PCDs

Tailored to your sterilization needs.

## Ready to get started?

Talk to a specialist about labeling.

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