Life Science Outsourcing, Inc.
Life Science Outsourcing (LSO) is an FDA-registered and ISO 13485-certified medical device contract manufacturer offering end-to-end solutions including assembly, packaging, sterilization, and testing.
Life Science Outsourcing (LSO) is a full-service, FDA-registered and ISO 13485-certified medical device contract manufacturer specializing in accelerating product launch and reducing costs. They provide comprehensive, end-to-end solutions under one roof, integrating assembly, kitting, packaging, and quick-turn sterilization. LSO offers services such as cleanroom device assembly, custom medical kits with traceability, and various sterilization modalities including EtO, steam, gamma, and ebeam, all with full validation to ISO 11135 and ISO 11137 standards. Their packaging testing team performs ISO 11607 validations, accelerated aging, seal integrity, and distribution simulation to ensure market readiness and regulatory compliance. As a single-source partner, LSO streamlines late-stage builds, reduces risk, lead time, and handoffs. They also provide cleaning and decontamination solutions for reusable devices and offer quality incubator services to support startups and medical device innovators in meeting investor expectations and achieving accelerated growth.
About
**Who they are**
Life Science Outsourcing, Inc. is an FDA-registered and ISO 13485-certified medical device contract manufacturer providing end-to-end solutions. They focus on accelerating product time to market and reducing costs through in-house expertise and comprehensive services.
**Expertise & scope**
* Integrating assembly, kitting, packaging, and quick-turn sterilization under one roof.
* Offering pre-validated packaging solutions and validation services.
* Providing packaging validation, testing, and design to meet regulatory requirements.
* Contract sterilization services for single-use and reusable products.
* Specializing in medical device manufacturing, assembly, sterilization, packaging, and distribution.
**Reputation / proof points**
* FDA-registered
* ISO 13485-certified
Life Science Outsourcing, Inc. is an FDA-registered and ISO 13485-certified medical device contract manufacturer providing end-to-end solutions. They focus on accelerating product time to market and reducing costs through in-house expertise and comprehensive services.
**Expertise & scope**
* Integrating assembly, kitting, packaging, and quick-turn sterilization under one roof.
* Offering pre-validated packaging solutions and validation services.
* Providing packaging validation, testing, and design to meet regulatory requirements.
* Contract sterilization services for single-use and reusable products.
* Specializing in medical device manufacturing, assembly, sterilization, packaging, and distribution.
**Reputation / proof points**
* FDA-registered
* ISO 13485-certified
Additional information
Life Science Outsourcing, Inc. emphasizes a partnership approach, acknowledging their role in client success and adapting to evolving customer needs. Their services are designed to integrate seamlessly, offering a comprehensive suite of solutions from assembly to distribution. Clients benefit from their in-house expertise and state-of-the-art equipment, ensuring regulatory compliance and efficient delivery to market. The company highlights its capacity, expertise, and capabilities to reliably meet tight deadlines and keep projects on track, supported by a deep understanding of regulatory processes.
Key Highlights
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FDA-registered and ISO 13485-certified medical device contract manufacturer.
Source
“Life Science Outsourcing (LSO) is an FDA-registered and ISO 13485-certified medical device contract manufacturer”
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Offers integrated assembly, kitting, packaging, and sterilization services.
Source
“comprehensive end-to-end solutions such as integrating assembly, kitting, packaging, and quick-turn sterilization – all under one roof.”
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Provides packaging validation, testing, and design to meet regulatory requirements.
Source
“Superior packaging validation, testing, and design that minimizes costs while ensuring all regulatory requirements are met.”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Medical device manufacturers seeking integrated manufacturing solutions
- Companies needing to accelerate time to market for new devices
- Businesses requiring specialized assembly, packaging, and sterilization services
How engagement typically works
- Partnership-focused approach
- End-to-end solution provider
- Adaptable to client needs
Typical deliverables
- Assembled medical devices
- Packaged medical devices
- Sterilized medical products
- Validated packaging solutions
- Distribution services
Good to know
- Best when seeking a single-source provider for multiple manufacturing steps.
HQ:
US
Languages:
English
Claim status:
Listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Countries:
United States, Asia
Industries:
Medical Devices
Pricing model:
Custom pricing
Iso10993 Standards Supported:
ISO 10993-1
Test Types Offered:
Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Genotoxicity, Implantation, Hemocompatibility, Pyrogenicity, Biodegradation
Is Accredited:
Yes
Glp Compliant:
No
Has In House Toxicology:
Yes
Contact Types Supported:
Surface contact, External communicating, Implant
Duration Types Supported:
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Lead Time Band:
Start in 4-8 weeks
Quote SLA:
3-5 business days
Sample Return Policy:
Dispose
Regions Served:
United States
Accreditation Body:
ISO 13485
Toxicology Capabilities:
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.
packaging_shelf_life_testing
