# History

> Explore the LSO history and its commitment to quality in medical device manufacturing with FDA registration and ISO certification.

Source: https://lso-inc.com/history/

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![History](https://lso-inc.com/api/media/file/DSC00941-3.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

## Accelerating Medical Innovation with End-to-End Contract Manufacturing

Life Science Outsourcing (LSO) is a trusted partner for medical device manufacturers, offering assembly, packaging, sterilization, and diagnostics packaging. With FDA registration and ISO 13485 certification, we support startups and established OEMs in bringing life-changing innovations to market faster.

## A Legacy of Innovation & Growth

### Over 25 Years of Expertise in Medical Device Manufacturing

For more than two decades, LSO has been at the forefront of contract manufacturing, serving hundreds of medical device companies across various specialties.

### The Acquisition of J-Pac Medical

In 2023, LSO acquired J-Pac Medical, expanding our expertise in custom medical packaging, precision thermoforming, and complex device assembly—reinforcing our leadership in end-to-end medical solutions.

## Commitment to Quality & Compliance

### Regulatory Excellence & Uncompromising Quality

Quality is at the core of everything we do. As an FDA-registered and ISO 13485-certified contract manufacturer, we maintain rigorous quality systems, including:

-   Annual ISO 13485 audits and ongoing certifications
-   Full lot traceability and advanced environmental monitoring
-   In-house sterilization validation and lot release procedures

[View Our Certifications](https://lso-inc.com/certifications/)

## Our Expert Team

### Meet the Experts Behind LSO’s Success

LSO’s leadership team and specialists bring decades of experience in medical device manufacturing, compliance, and engineering. Our collaborative approach ensures:

-   Deep regulatory expertise to navigate FDA & ISO requirements
-   Cross-functional engineering and manufacturing specialists
-   Dedicated project management for seamless execution

[View Our Team](https://lso-inc.com/?jet-engine=our-team)

## Markets We Serve

### Powering Innovation Across Medical Specialties

We partner with a diverse range of medical device companies across various specialties, including:

-   Orthopedics
-   Cardiovascular & Electrophysiology
-   Neuromodulation
-   Diagnostics & In Vitro Devices
-   Minimally Invasive Surgical Devices

[Learn More About the Markets we Serve](https://lso-inc.com/markets/)

## Global Facilities & Manufacturing Capabilities

### Bicoastal U.S. Operations & Nearshore Manufacturing in Costa Rica

LSO’s strategically located facilities offer seamless support from R&D to commercialization. Our sites include:

-   Brea, California – West Coast headquarters, specializing in medical device assembly, sterilization, and packaging
-   Somersworth, New Hampshire – East Coast operations with an advanced tooling center and prototyping lab
-   Costa Rica – Nearshore manufacturing for cost-efficient production and scalable solutions

**Each site is equipped with:**

-   125,000+ sq. ft. of dedicated manufacturing space
-   12 cleanrooms (Class 5 to 8) for sterile assembly and packaging
-   In-house sterilization (Steam & EtO) for rapid lot release
-   Warehouse and shipping infrastructure to support global distribution

[Explore Our Facilities](https://lso-inc.com/facilities-equipment/)

## Why LSO?

### Your Partner in Medical Device Innovation

Choosing LSO means working with a contract manufacturer that provides:

-   Regulatory Confidence – FDA-registered & ISO 13485-certified
-   End-to-End Solutions – From prototyping to packaging and sterilization
-   Global Manufacturing Reach – Bicoastal U.S. presence & nearshore capabilities
-   Flexible & Scalable Services – Supporting startups to multinational OEMs

## Work with LSO

[Request a Quote](https://lso-inc.com/contact/) [Explore Solutions](https://lso-inc.com/#solutions)