Life Science Outsourcing, Inc.

About Life Science Outsourcing, Inc.

Life Science Outsourcing, Inc. was established in 1997 in Anaheim, California, to provide contract manufacturing services to emerging medical device companies. The company operates three FDA‑registered facilities totaling over 125,000 square feet: its headquarters in Anaheim, California (80,000+ sq ft with eight cleanrooms), a packaging and validation site in Salem, New Hampshire, and an assembly and kitting operation in Zona Franca Coyol, Alajuela, Costa Rica. The company provides end‑to‑end medical device contract manufacturing, including cleanroom assembly (Class 5–8), packaging validation (ISO 11607), sterilization (EO, gamma, e‑beam), cleaning and decontamination, and fulfillment. Its 12 cleanrooms, a Class 7 dry room, and low‑humidity areas support bioabsorbable polymer processing. With over 125,000 square feet of FDA‑registered space across three sites, LSO handles projects from prototype through commercial scale, having supported more than 820 product launches for over 1,400 clients in 25 years. LSO serves medical device companies across orthopedics, cardiovascular and electrophysiology, neuromodulation, diagnostics (IVD/POC), minimally invasive devices, cardiac rhythm management, respiratory, gastrointestinal, dental implants, specialty kits, and oncology. Its customers range from early‑stage startups — such as a breast‑biopsy company that used LSO for turnkey assembly, packaging validation, and sterilization until its 2010 acquisition, and an orthopedic startup that relied on LSO for packaging and sterilization validation before a $130 million acquisition in 2004 — to established OEMs consolidating vendors. The company also supported rapid COVID‑19 swab production, achieving commercial distribution in four weeks. LSO differentiates itself by consolidating assembly, packaging, validation, sterilization, and distribution under a single FDA‑registered, ISO 13485‑certified quality system, eliminating vendor handoffs and reducing audit burden. The company states its model was created to give emerging medical device firms access to cleanroom infrastructure, quality systems, and regulatory guidance without building their own facilities, enabling faster time to market and lower supply‑chain risk.

Company details

Location

Somersworth, New Hampshire

Company type

Contract manufacturer / job shop

Founded

1997

Export compliance

Japan Minister of Health registration

Production volume

Prototype to commercial production

Certifications

ISO 13485:2016, ISO/IEC 17025:2017, ISO 11607, ISO 11135:2014, ISO 11137, ISO 17665-1:2006, ISO 10993

Listed under

• Medical Device Manufacturers in New Hampshire

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