Life Science Outsourcing, Inc.
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.
Company details
Find locations served, office locations
- Business Type:
- Service provider
- Industry Type:
- Medical Equipment
- Market Focus:
- Globally (various continents)
- Year Founded:
- 1997
This company also provides solutions for other industrial applications.
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Welcome
Since 1997, Life Science Outsourcing has partnered with more than 1,400 medical device innovators to streamline production and navigate complex regulatory requirements. We are an FDA-registered and ISO 13485-certified, performance-driven Contract Manufacturing Organization focused on medical device assembly, packaging, sterilization, and specialized-capabilities diagnostics packaging & design. Our unique business model emphasizes in-house, end-to-end process and service offerings, coupled with deep regulatory knowledge. This provides the agility and flexibility necessary to accelerate go-to-market launches, while standardizing supply chain and mitigating risk.
About Us
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