# Medical Device Packaging Development & Production

> Custom medical device packaging design, thermoforming, and ISO 11607-validated solutions from FDA-registered, ISO 13485-certified experts.

Source: https://lso-inc.com/packaging-development/

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[Get a Validation Plan Reviewed](https://lso-inc.com/solutions/packaging-validation/#intake-form)

![Medical Device Packaging Development & Production](https://lso-inc.com/api/media/file/preval_thumb_2025-3.jpg)

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

![Sterile Medical Device Packaging](https://lso-inc.com/api/media/file/preval_02_full_2025-3.jpg)

Accelerate your product launch with FDA-registered, ISO 13485-certified manufacturing. From cleanroom assembly to packaging, labeling, and sterilization—LSO delivers compliant, turnkey solutions for medical devices and implants.

## Custom-Engineered Packaging Solutionsfor Medical Devices

Medical device packaging is more than just a container—it's a critical component of product safety, sterility, and regulatory compliance. At Life Science Outsourcing (LSO), we provide comprehensive packaging development and production services designed to ensure regulatory compliance, durability, and a streamlined path to market.

As an FDA-registered, ISO 13485-certified contract manufacturer, our in-house packaging expertise includes custom design, thermoforming, and pre-validated sterile barrier solutions to accelerate commercialization while minimizing risks and costs.

Looking for expert medical device packaging solutions?

## Comprehensive Medical Device Packaging Services

## Package Design & Development

Developing the right medical device packaging requires precision engineering, regulatory expertise, and validation testing. LSO’s package design and development services include:

-   Custom sterile barrier system (SBS) development
-   Material selection to ensure durability and compliance
-   ISO 11607-compliant design and validation testing
-   Prototyping and small-batch production for rapid iteration

[Optimize your medical device packaging design](https://lso-inc.com/contact/)

![cad\_packaging\_001\_b](https://lso-inc.com/api/media/file/cad_packaging_001_b-3.jpg)

## Thermoforming for Medical Device Packaging

LSO specializes in precision thermoforming for rigid and semi-rigid medical device trays, providing protection, sterility, and ease of use. Our capabilities include:

-   Custom thermoformed trays for implants, instruments, and consumables
-   Material selection for PETG, HDPE, PVC, and Tyvek® compatibility
-   Validated processes to meet FDA and ISO 11607 standards
-   Prototype development and high-volume production

[Discover our thermoforming solutions](https://lso-inc.com/contact/)

## Pre-Validated Packaging Solutions

For medical device manufacturers looking to accelerate time-to-market, LSO offers pre-validated sterile packaging solutions that eliminate the need for lengthy validation processes. Our pre-validated packaging services include:

-   Off-the-shelf sterile barrier systems with ISO 11607 validation
-   Reduced time and costs associated with packaging compliance
-   Multiple size and material configurations to fit various devices
-   Turnkey solutions for faster regulatory approval

[Speed up your product launch with pre-validated packaging](https://lso-inc.com/contact/)

![Sterile Medical Device Packaging](https://lso-inc.com/api/media/file/preval_01_full_2025-3.jpg)

## Why LSO?

-   FDA-Registered, ISO 13485-Certified – Ensuring compliance with the highest industry standards
-   End-to-End Manufacturing & Assembly – From prototyping to full-scale production
-   Bicoastal & Nearshore Operations – Facilities in California, New Hampshire, and Costa Rica for cost-effective, scalable solutions
-   Quick-Turn Services – Faster sterilization, validation, and lot release to accelerate market entry
-   Proven Expertise in Medical Devices – Supporting orthopedics, neuromodulation, cardiovascular devices, and more

## Ready to get started?

[Get a Validation Plan Reviewed](https://lso-inc.com/solutions/packaging-validation/#intake-form) [Explore Solutions](https://lso-inc.com/#solutions)