# Why LSO — FDA-Registered Medical Device Contract Manufacturer

> FDA-registered, ISO 13485 certified. 12 cleanrooms, 125,000+ sq ft, 3 facilities. 25+ years of regulated manufacturing for medical devices, diagnostics, and combination products.

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

---

# Medical Device Manufacturing That Scales With Your Success

FDA-registered contract manufacturer supporting 820+ successful device launches with ISO 13485 certified processes across assembly, packaging, sterilization, and fulfillment.

[Get a Manufacturing Quote](https://lso-inc.com/contact/) [Tour Our Facilities](https://lso-inc.com/facilities/)

![Medical Device Manufacturing That Scales With Your Success](https://lso-inc.com/api/media/file/ManufacturingThatScales.webp)

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

## Proven Results Across 25+ Years

820+

Startup Launches

$4B+

Client Acquisition Value

125K+

Sq Ft Manufacturing

12

FDA Cleanrooms

## End-to-End Medical Device Contract Manufacturing

Life Science Outsourcing provides comprehensive contract manufacturing services for medical device companies, from early-stage startups to established enterprises. Our FDA-registered facilities in California, New Hampshire, and Costa Rica deliver scalable solutions that grow with your business.

With ISO 13485 certification and expertise across assembly, packaging, sterilization, and distribution, we eliminate the complexity of bringing medical devices to market while ensuring regulatory compliance at every step.

## Complete Manufacturing Capabilities Under One Roof

From prototype to commercial scale, we handle every aspect of medical device production

### Assembly & Kitting

Precision assembly in Class 5-8 cleanrooms with documented procedures and full traceability

### Packaging & Validation

ISO 11607 sterile barrier packaging with accelerated aging and transit validation

### Sterilization Services

EtO, gamma, and steam sterilization with ISO 11135/11137/17665 validation protocols

### Quality & Compliance

FDA 21 CFR Part 820 (QMSR) compliance with lot genealogy and complete documentation

### Global Distribution

Fulfillment and logistics services with temperature-controlled storage capabilities

### Rapid Scale-Up

Flexible capacity across three facilities to meet demand fluctuations and growth

## Our Manufacturing Process

1

### Project Assessment

We evaluate your device requirements, regulatory needs, and production timeline to develop a comprehensive manufacturing plan

2

### Process Development

Our engineering team designs and validates manufacturing processes, creates work instructions, and establishes quality controls

3

### Pilot Production

Small-scale production runs verify processes, identify optimization opportunities, and ensure consistent quality output

4

### Scale-Up & Launch

Full commercial production with real-time monitoring, lot genealogy tracking, and continuous improvement protocols

## Trusted by Medical Device Leaders

> “LSO's expertise in sterile packaging validation saved us months in our FDA submission timeline. Their attention to detail and regulatory knowledge is exceptional.”
> 
> Vo
> 
> VP of Operations
> 
> Class II Medical Device Manufacturer

> “From prototype assembly to commercial production, LSO scaled with our growth seamlessly. Their Costa Rica facility gave us the cost advantage we needed for international markets.”
> 
> C
> 
> CEO
> 
> Diagnostic Device Startup

## Explore Our Services

Specialized solutions for every stage of your medical device journey

[

### Assembly & Kitting

Precision assembly services in validated cleanroom environments

View Assembly Services](https://lso-inc.com/solutions/assembly-kitting/)

### Packaging Development

Sterile barrier packaging design and validation for medical devices

Explore Packaging](https://lso-inc.com/solutions/packaging-validation/)

### Sterilization & Validation

Comprehensive sterilization services with regulatory documentation

Get Sterilization Quote](https://lso-inc.com/solutions/sterilization-validation/)

### Cleaning & Decontamination

Validated cleaning processes for medical devices and components

Learn About QSR](https://lso-inc.com/solutions/cleaning-decontamination/)

## Ready to Scale Your Medical Device Manufacturing?

Get a custom manufacturing plan with timeline and cost estimates for your device.

[Get a Manufacturing Quote](https://lso-inc.com/contact/) [Schedule a Facility Tour](https://lso-inc.com/contact/?tour=true)

Or call us directly: [(714) 672-1090](tel:7146721090)