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. (LSO) 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. (LSO) 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 growth and success. They continuously adapt to customer needs, offering comprehensive solutions that integrate assembly, kitting, packaging, and sterilization. Clients benefit from access to pre-validated packaging and validation services, designed to minimize costs while ensuring regulatory compliance. Their services span various medical device manufacturing specialties, offering flexibility for market success. They highlight having all relevant certifications and an in-depth understanding of regulatory processes, ensuring projects stay on track and meet tight deadlines.
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 end-to-end solutions including assembly, packaging, sterilization, and testing.
Source
“offering end-to-end solutions including assembly, packaging, sterilization, and testing.”
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Focuses on accelerating product time to market and reducing overall costs.
Source
“accelerate your product’s time to market and reduce overall costs with elevated efficiency”
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Provides pre-validated packaging solutions and validation services.
Source
“Clients also benefit from access to pre-validated packaging solutions and validation services”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Medical device manufacturers seeking integrated manufacturing solutions.
- Companies needing accelerated time-to-market for their products.
- Businesses requiring end-to-end services from assembly to sterilization and packaging.
How engagement typically works
- Partnership-focused approach.
- Adaptable to evolving customer needs.
- Emphasis on in-house expertise and efficiency.
Typical deliverables
- Medical device assembly and kitting.
- Packaging validation, testing, and design.
- Contract sterilization services.
- Fulfillment and distribution.
Good to know
- Best when requiring a comprehensive suite of services under one roof.
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, ISO 10993-10, ISO 10993-11
Test Types Offered:
Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Genotoxicity, Implantation, Biodegradation, Other
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. As a single-source, end-of-line partner, LSO reduces risk, lead time and handoffs so your device reaches patients safely and efficiently. 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. Speed Time-To-Market: Open Capacity, Process Efficiency, and Expert In-House Guidance for EtO, Gamma, E-Beam, and Steam Sterilization Methods Medical device package testing and validation for ISO 11607, ASTM, and FDA compliance—seal integrity, aging studies, and transit simulation services. 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.
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