LSO: Medical Device Contract Manufacturing, Packaging & Sterilization
FDA-registered and ISO 13485-certified, providing consolidated assembly, packaging, testing and sterilization services.
Medical Device Assembly & Kitting
Cleanroom device assembly and custom medical kits with traceability and documentation.
In-House and Managed Sterilization Services
EtO, steam, gamma, and ebeam sterilization with full validation to ISO 11135 and ISO 11137.
Medical Device Package Testing
ISO 11607 packaging validation, accelerated aging, seal integrity, and distribution simulation.
Single-source end-of-line solutions
Life Science Outsourcing (LSO) provides medical device kitting, sterilization and packaging testing for OEMs and startups—FDA-registered and ISO 13485-certified. Our cleanroom assembly & kitting capabilities streamline late-stage builds and documentation. We coordinate multiple sterilization modalities—EtO, steam, gamma and ebeam—with full validations to ISO 11135 and ISO 11137. To ensure packaging compliance and market readiness, our packaging testing team performs ISO 11607 validations, including accelerated aging, seal integrity and distribution simulation. As a single-source, end-of-line partner, LSO reduces risk, lead time and handoffs so your device reaches patients safely and efficiently. Talk to an LSO Specialist.
Discover LSO's Single-Source Solutions
Startup
Empowering innovation and accelerating your journey to market with flexible, cost-effective solutions designed to scale with your startup’s growth
Commercial OEM
Empowering your innovation and accelerating time-to-market with scalable, end-to-end assembly, packaging, and sterilization solutions designed to meet the rigorous demands of global commercialization
Medical Device Assembly & Kitting
Accelerate your product launch with FDA-registered, ISO 13485-certified manufacturing. From cleanroom assembly to packaging, labeling, and sterilization—LSO delivers compliant, turnkey solutions for medical devices and implants.
In-House and Managed Sterilization Processing
Speed Time-To-Market: Open Capacity, Process Efficiency, and Expert In-House Guidance for EtO, Gamma, E-Beam, and Steam Sterilization Methods
Package Testing & Validation
Medical device package testing and validation for ISO 11607, ASTM, and FDA compliance—seal integrity, aging studies, and transit simulation services.
Packaging Development & Production
Accelerate your product launch with FDA-registered, ISO 13485-certified manufacturing. From cleanroom assembly to packaging, labeling, and sterilization—LSO delivers compliant, turnkey solutions for medical devices and implants.
Point of Care Diagnostics
Cleaning & Decontamination
Validated cleaning, decontamination, and inspection services for reusable and single-use medical devices in FDA-registered, ISO-certified facilities.
Medical Device Incubator Support
Fulfillment & Distribution
Validation Testing Services
Explore our full range of critical validation testing services—trusted methods to ensure your medical devices meet the highest safety and compliance standards.