Life Science Outsourcing, Inc.
LSO provides comprehensive medical device packaging and testing services, including ISO 11607 validation, accelerated aging, and distribution simulation to ensure product safety and market readiness.
Life Science Outsourcing (LSO) is an FDA-registered and ISO 13485-certified provider specializing in medical device packaging and testing. They offer end-to-end solutions designed to accelerate time-to-market and reduce costs for OEMs and startups. Key services include ISO 11607 packaging validation (Parts 1 & 2), accelerated aging studies (ASTM F1980), and distribution simulation testing (ISTA, ASTM D4169). LSO ensures sterile barrier systems are designed, sealed, tested, and proven to protect devices through their shelf life and open aseptically at the point of use. Their expertise extends to cleanroom assembly, kitting, sterilization (EtO, steam, gamma, ebeam), and supply chain management. LSO acts as a single-source partner, streamlining processes from initial planning to final reporting, ensuring compliance with global standards and audit-readiness.
About
**Who they are**
Life Science Outsourcing, Inc. (LSO) provides comprehensive medical device packaging and testing services designed to accelerate product time to market and reduce costs through in-house expertise and end-to-end solutions.
**Expertise & scope**
* Integrates assembly, kitting, packaging, and quick-turn sterilization under one roof.
* Offers pre-validated packaging solutions and validation services.
* Specializes in medical device packaging and testing, including ISO 11607 validation, accelerated aging, and distribution simulation.
* Provides contract sterilization services for single-use and reusable products.
* Expertise in packaging validation, testing, and design to meet regulatory requirements.
**Reputation / proof points**
* Operates with a focus on partnership, quality, and regulatory experience.
* Possesses all relevant certifications and an in-depth understanding of regulatory processes.
* Demonstrates capacity, expertise, and capabilities to meet tight deadlines.
Life Science Outsourcing, Inc. (LSO) provides comprehensive medical device packaging and testing services designed to accelerate product time to market and reduce costs through in-house expertise and end-to-end solutions.
**Expertise & scope**
* Integrates assembly, kitting, packaging, and quick-turn sterilization under one roof.
* Offers pre-validated packaging solutions and validation services.
* Specializes in medical device packaging and testing, including ISO 11607 validation, accelerated aging, and distribution simulation.
* Provides contract sterilization services for single-use and reusable products.
* Expertise in packaging validation, testing, and design to meet regulatory requirements.
**Reputation / proof points**
* Operates with a focus on partnership, quality, and regulatory experience.
* Possesses all relevant certifications and an in-depth understanding of regulatory processes.
* Demonstrates capacity, expertise, and capabilities to meet tight deadlines.
Additional information
LSO's services are structured to support the entire lifecycle of medical device packaging, from initial design and validation through to distribution and shelf-life determination. They emphasize a partnership approach, working closely with clients to navigate complex regulatory landscapes. Clients can expect a focus on efficiency and cost reduction, leveraging LSO's integrated capabilities. Engagement typically involves defining specific testing protocols, such as accelerated aging per ASTM F1980 or ISO 11607 packaging validation, followed by execution and reporting.
Key Highlights
-
Provides comprehensive medical device packaging and testing services, including ISO 11607 validation, accelerated aging, and distribution simulation.
Source
“LSO provides comprehensive medical device packaging and testing services, including ISO 11607 validation, accelerated aging, and distribution simulation to ensure product safety and market readiness.”
-
Offers integrated end-to-end solutions such as assembly, kitting, packaging, and quick-turn sterilization under one roof.
Source
“comprehensive end-to-end solutions such as integrating assembly, kitting, packaging, and quick-turn sterilization – all under one roof.”
-
Performs accelerated aging testing following the ASTM F1980 standard to help establish initial shelf-life claims.
Source
“Accelerated aging is a standardized method that uses elevated temperatures to simulate the long-term shelf life of a sterilized medical device package within weeks instead of years, following the ASTM F1980 accelerated aging standard.”
-
Specializes in ISO 11607 packaging validation, covering both Part 1 (materials & sterile barrier systems) and Part 2 (process validation).
Source
“ISO 11607 defines how your sterile barrier system is designed, sealed, tested, and proven—from first article through shelf life. This guide explains Part 1 (materials & sterile barrier systems) and Part 2 (process validation)”
Certifications & Trust Signals
-
Possesses all relevant certifications and an in-depth understanding of regulatory processes.
Source
“We have all relevant certifications and an in-depth understanding of regulatory processes.”
-
Demonstrates capacity, expertise, and capabilities to reliably meet tight deadlines and keep projects on track.
Source
“Our capacity, expertise and capabilities reliably meet tight deadlines and keep projects on track.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking integrated packaging and testing solutions.
- Companies needing to validate sterile barrier systems according to ISO 11607.
- Providers requiring accelerated aging studies to support shelf-life claims.
How engagement typically works
- Partnership-focused approach.
- Collaborative service delivery.
- End-to-end solution integration.
Typical deliverables
- Validated packaging designs.
- Accelerated aging test reports.
- Distribution simulation test results.
- Sterilization validation documentation.
- Assembly and kitting services.
Good to know
- Best when clients require specialized medical device packaging and shelf-life testing expertise.
- Ideal for projects needing to meet stringent regulatory requirements like ISO 11607 and ASTM standards.
Pricing
Model:
Custom pricing
HQ:
Brea, US
Languages:
English
Timezones:
America/Los_Angeles
Claim status:
Listed
Services & Capabilities
Packaging + Shelf-life + Distribution Testing
Countries:
United States, Asia
Industries:
Medical Devices
Pricing model:
Custom pricing
Packaging Tests Offered:
Package integrity, Seal strength, Burst strength
Shelf Life Methods Offered:
Real-time aging, Accelerated aging, Both
Distribution Tests Offered:
Other
Standards Supported:
ISO 11607, ISO 13485, FDA Guidance, ASTM D4169, ISTA
Has Climate Chambers:
No
Has Distribution Simulation:
Yes
Rush Available:
No
Nda Support:
No
Lead Time Band:
Start in 0-2 weeks
Quote SLA:
< 24 hours
Sample Return Policy:
Dispose
Minimum Project Size:
No minimum
Additional packaging_shelf_life_testing Details
Packaging Tests Offered
Package integrity, Heat seal validation, Accelerated aging, Real time aging, Environmental conditioning, Distribution simulation testing, Visual inspection, Bubble emission testing, Dye penetration testing, Peel strength testing, Stability testing
Standards Supported
ISO 11607, ASTM D3078, ASTM D4169, ASTM D4332, ASTM D4728, ASTM D5265, ASTM D5276, ASTM D642, ASTM D999, ASTM D6653, ASTM D6344, ASTM F1140, ASTM F1929, ASTM F1980, ASTM F1886, ASTM F88, ASTM F2096, ASTM F3039, ISTA 1A, ISTA 1G, ISTA 2A, ISTA 3A
Shelf Life Methods Offered
Real-time aging, Accelerated aging, Both
Distribution Tests Offered
Distribution simulation testing, Vibration, Shock, Drop, Compression, Stacking, Climate
Lead Time Band
Start in 0-2 weeks
Quote SLA
< 24 hours
Sample Return Policy
Return, Dispose, Both options
Minimum Project Size
No minimum
Pricing Model
Per project
