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