Company
Innovative medical device assembly, packaging, and sterilization — FDA-registered, ISO 13485-certified, and trusted by 1,400+ companies over 25 years.
Established in 1997, Life Science Outsourcing, Inc. was founded to offer contract manufacturing services to emerging medical device companies. As an FDA-registered and ISO 13485-certified contract manufacturing organization, we offer assembly, packaging, sterilization, and specialized capabilities in diagnostics packaging and design. Our unique business model combines comprehensive in-house services and extensive regulatory expertise, allowing us to provide the agility and flexibility needed to expedite market launches while standardizing the supply chain and minimizing risks.
Quality is our Hallmark
Life Science Outsourcing (LSO) is a full-service medical device contract manufacturer with a steadfast commitment to quality. Our certifications and proprietary processes ensure regulatory compliance and tailored expertise across the product development process.
We demonstrate this commitment through:
- Maintaining FDA registration and ISO 13485 certification across all facilities
- Annual ISO 13485 surveillance audits and full quality management system certifications
- Frequent third-party and customer quality system audits
- Lot traceability to suppliers raw material lot numbers through our ERP system
- Controlled labeling process and a dedicated secure room
Our Team
Life Science Outsourcing is a dedicated and diverse team of regulatory experts, industry innovators, and client collaborators focused on advancing innovation and improving lives. We bring your medical device innovations to life by building true partnerships based on transparency, and leverage a wide range of technical and management experience for every project we take on. Our shared commitment to customer success fuels our passion for the work we do.
Markets We Serve
At LSO, we specialize in transforming medical device concepts into commercialized products across diverse MedTech markets with vast growth potential. Though we consider ourselves market-agnostic, we possess extensive expertise and a proven track record in various sectors, including Orthopedics, Cardiovascular and Electrophysiology, Neuromodulation, Diagnostics, Minimally Invasive Devices, and Cardiac Rhythm Management, among others.
Our Facilities & Equipment
Life Science Outsourcing facilities span over 125,000 square feet across California, New Hampshire, and Costa Rica, and are dedicated to medical device manufacturing, assembly, packaging, and sterilization. We offer 12 cleanrooms ranging from Class 5 to 8, a Class 7 dry room, low-humidity manufacturing, and solvent scouring areas for bioabsorbable polymers. Additionally, each site has over 30,000 square feet of warehouse space with multiple shipping and receiving bays for versatile material and product handling.
Frequently Asked Questions
LSO works with medical device companies of many sizes and types. Our model is best suited for organizations seeking turnkey solutions, cost and efficiency savings, reduced overhead, flexibility to focus on core activities, quicker time to market, access to industry expertise, staffing flexibility, and risk management.
LSO has been in business for nearly 25 years and has served more than 1,400 companies. We specialize in orthopedic, cardiac rhythm systems, cardiovascular, neurovascular, respiratory, gastrointestinal, dental implants, minimally invasive devices, specialty kits, and oncology sectors.
We operate under a Non-Disclosure Agreement with all companies prior to beginning discussions. When these companies become customers, they are assigned a three-letter code to protect their privacy. All internal discussions, documentation, and warehousing facilities reflect only the company's letter code to ensure privacy and confidentiality.
LSO provides Class 10,000/ISO 7-rated cleanroom space to early-stage companies that may not be registered with the FDA or that do not have their own facilities. We offer the option to rent cleanroom space on a daily basis to build prototypes or small lots, and use equipment and engineering staff to assist in the early stages of product development.
LSO operates three facilities: our headquarters in Anaheim, California (80,000+ sq ft with 8 cleanrooms), LSO East in Salem, New Hampshire (package testing and validation), and LSO Costa Rica in Zona Franca Coyol, Alajuela (assembly and kitting operations). Combined, we have over 125,000 sq ft of FDA-registered manufacturing space.
We maintain FDA CDRH Registration (Contract Manufacturer, Contract Sterilizer), State of California Device and Drug Manufacturing Licenses, ISO 13485:2016, ISO 17665-1:2006 (Moist Heat Sterilization), ISO 11135:2014 (EO Sterilization), Japan Minister of Health registration, ISTA Certified Package Testing Laboratory, and California Board of Pharmacy Drug Wholesaler License.
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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