Life Science Outsourcing, Inc.
LSO provides comprehensive medical device sterilization, packaging, and testing services. They are FDA-registered and ISO 13485-certified, offering end-to-end solutions for OEMs and startups.
Life Science Outsourcing (LSO) is an FDA-registered and ISO 13485-certified provider specializing in end-to-end solutions for the medical device industry. They offer a full suite of services including cleanroom assembly, kitting, packaging, labeling, and sterilization. LSO coordinates multiple sterilization modalities such as EtO, steam, gamma, and ebeam, ensuring full validation to ISO 11135 and ISO 11137 standards. Their packaging testing services include ISO 11137 validations for accelerated aging, seal integrity, and distribution simulation, ensuring market readiness and regulatory compliance. As a single-source partner, LSO streamlines late-stage builds and documentation, reducing risk, lead time, and handoffs. They empower innovation and accelerate time-to-market with flexible, cost-effective solutions designed to scale with client growth, from startups to commercial OEMs.
About
**Who they are**
Life Science Outsourcing, Inc. (LSO) is an FDA-registered and ISO 13485-certified full-service medical device contract manufacturer specializing in sterilization, packaging, and testing services.
**Expertise & scope**
* Provides comprehensive medical device sterilization, packaging, and testing services.
* Offers end-to-end solutions for OEMs and startups.
* Expertise in sterilization validation engineering and testing.
* Services include validation of ethylene oxide (EO), radiation (gamma and eBeam), and steam sterilization processes.
* Performs validation testing to support product development, sterilization validation, and commercial release.
* Supports regulatory compliance, product release, and ongoing manufacturing.
* Specializes in steam sterilization cycle validation and cleaning validation.
**Reputation / proof points**
* FDA-registered facilities
* ISO 13485-certified facilities
Life Science Outsourcing, Inc. (LSO) is an FDA-registered and ISO 13485-certified full-service medical device contract manufacturer specializing in sterilization, packaging, and testing services.
**Expertise & scope**
* Provides comprehensive medical device sterilization, packaging, and testing services.
* Offers end-to-end solutions for OEMs and startups.
* Expertise in sterilization validation engineering and testing.
* Services include validation of ethylene oxide (EO), radiation (gamma and eBeam), and steam sterilization processes.
* Performs validation testing to support product development, sterilization validation, and commercial release.
* Supports regulatory compliance, product release, and ongoing manufacturing.
* Specializes in steam sterilization cycle validation and cleaning validation.
**Reputation / proof points**
* FDA-registered facilities
* ISO 13485-certified facilities
Additional information
LSO's Sterilization Validation Services (SVS) division provides in-house sterilization capabilities and managed modalities supported by defined standards and quality system controls. They offer a streamlined, one-stop-shop approach to address common obstacles in the sterilization process, such as limited capacity, complex vendor management, and adherence to standards. Their services are designed to support regulatory compliance, product release, and ongoing manufacturing for medical devices.
Key Highlights
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Provides comprehensive medical device sterilization, packaging, and testing services.
Source
“LSO provides comprehensive medical device sterilization, packaging, and testing services.”
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Offers end-to-end solutions for medical device OEMs and startups.
Source
“offering end-to-end solutions for OEMs and startups.”
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Services include validation of ethylene oxide (EO), radiation (gamma and eBeam), and steam sterilization processes.
Source
“Services include validation of ethylene oxide (EO), radiation (gamma and eBeam), and steam sterilization processes”
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Operates within FDA-registered and ISO 13485-certified facilities.
Source
“Life Science Outsourcing (LSO) provides medical device sterilization validation engineering and testing services in FDA-registered, ISO 13485-certified facilities.”
Certifications & Trust Signals
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FDA-registered facilities
Source
“Within Life Science Outsourcing’s Sterilization Validation Services (SVS) division, sterilization services are provided through in-house sterilization capabilities”
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ISO 13485-certified facilities
Source
“Within Life Science Outsourcing’s Sterilization Validation Services (SVS) division, sterilization services are provided through in-house sterilization capabilities”
Buyer Snapshot
Best for
- Medical device manufacturers requiring sterilization validation.
- Companies seeking end-to-end sterilization, packaging, and testing solutions.
- Startups and OEMs needing regulatory compliance support.
How engagement typically works
- Project-based validation services.
- Contract sterilization and validation support.
- End-to-end solution provider.
Typical deliverables
- Sterilization validation reports (IQ/OQ/PQ).
- Validated sterilization processes (EtO, Gamma, E-Beam, Steam).
- Medical device testing reports.
- Documentation for regulatory compliance.
Good to know
- Best when requiring FDA-registered and ISO 13485-certified services.
- Best when needing support for various sterilization methods including EtO, Gamma, E-Beam, and Steam.
HQ:
US
Languages:
English
Status:
listed
Services & Capabilities
Sterilization + Microbiology Validation
Countries:
United States, Asia
Industries:
Medical Devices
Sterilization Methods Supported:
EtO (Ethylene Oxide), Steam (Moist Heat), Gamma Radiation, E-Beam
Validation Types Offered:
Full validation (IQ/OQ/PQ), Revalidation, Other
Microbiology Tests Offered:
Bioburden, Sterility, Environmental monitoring, Other
Standards Supported:
ISO 11135 (EtO), ISO 11137 (Radiation), ISO 17665 (Steam), ISO 11737-1 (Bioburden), ISO 11737-2 (Sterility)
Is Accredited:
Yes
GMP Compliant:
Yes
Has In House Sterilization:
Yes
Has In House Microbiology:
Yes
Rush Available:
Yes
Additional sterilization_microbiology_testing Details
Sterilization Methods Supported
Steam (Moist Heat), Gamma Radiation, Electron Beam (E-Beam), Ethylene Oxide (EtO)
Validation Types Offered
Steam Sterilization Cycle Validation, Cleaning Validation, Full validation (IQ/OQ/PQ)
Microbiology Tests Offered
Sterility, Biological safety, Process effectiveness
Lead Time Band
Start in 4-8 weeks
Quote SLA
< 24 hours
Pricing Model
Per project
