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 a partnership approach.
**Expertise & scope**
* Integrating assembly, kitting, and packaging services.
* Offering quick-turn sterilization and validation services.
* Providing packaging validation, testing, and design to meet regulatory requirements.
* Contract sterilization for single-use and reusable products.
* Comprehensive solutions including cleaning, decontamination, fulfillment, and distribution.
**Reputation / proof points**
* FDA-registered
* ISO 13485-certified
* In-house expertise
* State-of-the-art medical device manufacturing equipment
* In-depth understanding of regulatory processes
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 a partnership approach.
**Expertise & scope**
* Integrating assembly, kitting, and packaging services.
* Offering quick-turn sterilization and validation services.
* Providing packaging validation, testing, and design to meet regulatory requirements.
* Contract sterilization for single-use and reusable products.
* Comprehensive solutions including cleaning, decontamination, fulfillment, and distribution.
**Reputation / proof points**
* FDA-registered
* ISO 13485-certified
* In-house expertise
* State-of-the-art medical device manufacturing equipment
* In-depth understanding of regulatory processes
Additional information
Life Science Outsourcing, Inc. emphasizes a collaborative partnership model, aiming to foster client growth and success. Their services are designed to be comprehensive, offering integrated solutions for assembly, sterilization, packaging, and distribution under one roof. Clients can leverage pre-validated packaging solutions and validation services to streamline market delivery. The company highlights its adaptability to evolving customer needs and its commitment to serving specialized markets with elevated efficiency.
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 end-to-end solutions including assembly, kitting, packaging, and sterilization.
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
- Providers requiring end-to-end assembly, packaging, and sterilization services
How engagement typically works
- Partnership-focused approach
- End-to-end solution integration
- Adaptable to client needs
Typical deliverables
- Medical device assembly
- Packaging and kitting
- Sterilization and validation
- Cleaning and decontamination
- Fulfillment and distribution
Good to know
- Best when integrated services are required under one roof.
HQ:
US
Languages:
English
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
