LSO | Medical Device Contract Manufacturing, Assembly & 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.

Learm more about Medical Device Assembly & Kitting

In-House and Managed Sterilization Services

EtO, steam, gamma, and ebeam sterilization with full validation to ISO 11135 and ISO 11137.

Learm more about Sterilization Processing

Medical Device Package Testing

ISO 11607 packaging validation, accelerated aging, seal integrity, and distribution simulation.

Learm more about Medical Device Package Testing

years in business

customers served

startups assisted

acquisition value created

$ 0 B

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.

Learm more about Medical Device Assembly & Kitting

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

Learm more about Sterilization Processing

Package Testing & Validation

Medical device package testing and validation for ISO 11607, ASTM, and FDA compliance—seal integrity, aging studies, and transit simulation services.

Learm more about Medical Device Package Testing & Validation

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.​

Learm more about Packaging Development & Production

Point of Care Diagnostics

End-to-end manufacturing for diagnostic devices, reagents, and consumables with FDA-registered, ISO 13485-certified cleanroom services.

Learm more about 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.

Learm more about Cleaning & Decontamination Services

Medical Device Incubator Support​

Incubator services for MedTech startups with cleanroom rental, QMS support, DHF development, and UDI compliance in FDA-registered, ISO-certified facilities.

Learn more about Medical Device Incubator Services

Fulfillment & Distribution​

FDA-registered, ISO-certified fulfillment, warehousing, and shipping services for medical devices with full traceability and global distribution.

Learm more about Fulfillment & Distribution Services

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.