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 medical device contract manufacturer providing comprehensive sterilization, packaging, and testing services. They aim to accelerate product time-to-market and reduce costs through in-house expertise and end-to-end solutions.
**Expertise & scope**
* Offers a full suite of services including medical device assembly, kitting, packaging, cleaning, passivation, fulfillment, and distribution.
* Provides contract sterilization services for both single-use and reusable products, covering a range of methods.
* Specializes in sterilization validation, including process development, validation testing, and routine control, adhering to industry standards.
* Expertise in various sterilization modalities: Gamma, E-Beam, EtO (Ethylene Oxide), Steam (Moist Heat), and Dry Heat.
* Conducts post-sterilization testing to ensure sterility levels are met and assists with interpreting results.
**Reputation / proof points**
* FDA-registered
* ISO 13485-certified
Life Science Outsourcing, Inc. (LSO) is an FDA-registered and ISO 13485-certified medical device contract manufacturer providing comprehensive sterilization, packaging, and testing services. They aim to accelerate product time-to-market and reduce costs through in-house expertise and end-to-end solutions.
**Expertise & scope**
* Offers a full suite of services including medical device assembly, kitting, packaging, cleaning, passivation, fulfillment, and distribution.
* Provides contract sterilization services for both single-use and reusable products, covering a range of methods.
* Specializes in sterilization validation, including process development, validation testing, and routine control, adhering to industry standards.
* Expertise in various sterilization modalities: Gamma, E-Beam, EtO (Ethylene Oxide), Steam (Moist Heat), and Dry Heat.
* Conducts post-sterilization testing to ensure sterility levels are met and assists with interpreting results.
**Reputation / proof points**
* FDA-registered
* ISO 13485-certified
Additional information
LSO emphasizes a partnership approach, adapting to customer needs with comprehensive end-to-end solutions. They offer access to pre-validated packaging and validation services to facilitate market delivery. Their services are designed to streamline processes, particularly for sterilization, by providing open capacity, reducing reliance on multiple vendors, and offering in-house expertise, including a dedicated microbiologist. They highlight their ability to handle both initial sterilization and periodic revalidation, archiving process records to remind clients of upcoming revalidation needs.
Key Highlights
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Offers contract sterilization and validation for single-use and reusable medical devices.
Source
“LSO offers comprehensive contract sterilization services and expertise to guide all medical device clients through the sterilization and validation of single use and reusable products and related documentation.”
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Supports multiple sterilization methods including Gamma, E-Beam, EtO, Steam, and Dry Heat.
Source
“SVS offers all popular sterilization methods including Gamma, E-Beam, EtO, Steam and Dry Heat.”
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Provides comprehensive medical device assembly, packaging, kitting, and fulfillment services.
Source
“comprehensive end-to-end solutions such as integrating assembly, kitting, packaging, and quick-turn sterilization – all under one roof.”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Medical device manufacturers seeking end-to-end sterilization and packaging solutions.
- Companies needing to accelerate time-to-market for new or existing devices.
- Startups and OEMs requiring regulatory-compliant sterilization and validation.
How engagement typically works
- Partnership-focused approach.
- Consultative support for methodology selection and regulatory navigation.
- Turnkey solutions from validation to testing and sterilization.
Typical deliverables
- Validated sterilization processes (EtO, Steam, Gamma, E-Beam).
- Sterilization validation reports.
- Packaging validation and testing.
- Medical device assembly and kitting.
- Cleaning and passivation services.
Good to know
- Best when requiring integrated services under one roof.
- Best when needing to meet stringent regulatory requirements (FDA, ISO).
HQ:
Brea, US
Languages:
English
Timezones:
America/Los_Angeles
Claim status:
Listed
Services & Capabilities
Sterilization + Microbiology Validation
Countries:
United States, Asia
Industries:
Medical Devices
Pricing model:
Custom pricing
Sterilization Methods Supported:
EtO (Ethylene Oxide), Steam (Moist Heat), Gamma Radiation, E-Beam
Validation Types Offered:
Revalidation, Full validation (IQ/OQ/PQ)
Microbiology Tests Offered:
Bacterial Endotoxin (LAL), Sterility
Standards Supported:
ISO 11135 (EtO), ISO 11137 (Radiation), ISO 17665 (Steam)
Is Accredited:
Yes
GMP Compliant:
Yes
Has In House Sterilization:
Yes
Has In House Microbiology:
Yes
Rush Available:
Yes
Accreditation Body:
ISO
Glp Compliant:
Yes
Quote SLA:
< 24 hours
Nda Support:
Yes
Lead Time Band:
Start in 0-2 weeks
Additional sterilization_microbiology_testing Details
Sterilization Methods Supported
EtO, Steam (Moist Heat), Gamma Radiation, E-Beam, Dry Heat
Validation Types Offered
Sterilization Validation, Revalidation, Process Development, Validation Testing
Microbiology Tests Offered
Sterility testing, Bacterial Endotoxin Testing
Lead Time Band
Start in 0-2 weeks
Quote SLA
< 24 hours
Pricing Model
Custom
