Life Science Outsourcing, Inc.

Life Science Outsourcing (LSO) is an FDA-registered, ISO 13485-certified contract manufacturer and outsourcing partner specializing in medical device assembly, sterilization processing, and packaging validation. The company provides end-of-line manufacturing services including cleanroom device assembly and custom medical kitting with full traceability and regulatory documentation. LSO operates in-house sterilization services across multiple modalities—EtO (ethylene oxide), steam, gamma, and electron beam (ebeam)—with validation to ISO 11135 and ISO 11137 standards. The company also delivers comprehensive ISO 11607 packaging testing and validation, including accelerated aging studies, seal integrity assessment, and distribution simulation. Additional capabilities include cleaning and decontamination services for reusable and single-use devices, medical device incubator support for MedTech startups (with QMS support, DHF development, and UDI compliance assistance), packaging development and production, point-of-care diagnostics manufacturing, fulfillment and distribution with global logistics, and validation testing services. LSO serves OEM medical device manufacturers, startups, and contract development organizations across cardiovascular, orthopedic, diagnostic, dental, ophthalmic, and other specialties. The company operates two facilities: LSO West in Brea, California and LSO East in Somersworth, New Hampshire, positioning itself as a single-source, turnkey solution to reduce lead time, regulatory risk, and handoffs for device manufacturers bringing products to market.