Dedicated Client Commitment Throughout
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 focus on assembly, packaging, sterilization, and specialized capabilities in diagnostics packaging & 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 an FDA-registered and ISO 13485-certified 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. LSO’s dedication to quality is evident in the robust systems established in our U.S. and Costa Rica facilities, as well as the individual ownership our employees take over our quality procedures on a daily basis.
We demonstrate this commitment through:
- Maintaining FDA registration and ISO 13485 certification and a range of other certifications that underline our unwavering commitment to superior quality management and risk mitigation in the medical device assembly field.
- Annual ISO 13485 surveillance audits and full Quality Management System certifications for all of our facilities
- Frequent third-party and customer quality system audits
- Monthly non-viable testing, daily differential pressure monitoring and quarterly viable testing
- Lot traceability to suppliers’ raw material lot numbers through our ERP system
- Controlled labeling process and a dedicated secure room
- Lot release, including sterilization release
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, leveraging a wide range of technical and management experience on 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 & Electrophysiology, Neuromodulation, Diagnostics, Minimally Invasive Devices, and Cardiac Rhythm Management, among others.
Our Facilities & Equipment
Our facilities at Life Science Outsourcing span over 125,000 square feet across California, New Hampshire, and Costa Rica, 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
Find more details about Life Science Outsourcing and how we bring medical innovations to life.