Supplier Information

Life Science Outsourcing -  is a full service Medical Device Contract Manufacturer.  In addition to turnkey manufacturing services they also provide:  documentation creation, materials soucing and procurement, packaging design & testing, validation, sterilization, product decontamination and distribution services for disposable, reusable and loaner kit processing  of medical products.

In Alpha sort
Life Science Outsourcing is an FDA registered and ISO 13485:2003 certified full service Medical Device Contract Manufacturer, located in Orange County, California.
They are the premier outsource solution for the medical device, biomedical, pharmaceutical and diagnostic industries.  LSO is a rapidly growing company offering a wide range of services through its various divisions.

At LSO, they believe that business is a partnership. They understand the critical role they play in the growth and success of client companies and take the responsibility seriously. Their ability to understand and continuously respond to the ever-changing needs of clients are the key factors behind their rapid growth and success.

MEDICAL DEVICE MANUFACTURING
Providing assembly, packaging and sterilization services including sterilization validation.  Client companies receive finished sterile product, with complete documentation, ready for release to their distribution network.  LSO maintains complete traceability and device history records for every lot produced. 

MEDICAL PACKAGE TESTING

LSO is an ISTA certified packaging test lab (ID Number ST-2339), devoted to the validation, testing and design of packaging for medical device manufacturers, pharmaceutical companies, biotech companies, and the diagnostic industry. Their testing and validation services are based on ISO 11607-1:2006 and are designed to assure compliance with FDA, ISO, EN and CE Mark requirements.

Services include:
Stability Testing -Accelerated and Real-Time Aging.
Distribution Simulation
Package Integrity Testing
Package Validation & Quality Assurance

STERILIZATION VALIDATION SERVICES

Providing contract sterilization services to their clients including: 
Consulting
Medical Device Sterilization  (Gamma, E-Beam, EtO, Steam and Dry Heat)
Sterility Testing
Validation of Sterilization Process.

FULFILLMENT & DISTRIBUTION SERVICES

Designed to meet the needs of young companies who require controlled storage and distribution of finished goods to multiple sites.  LSO is perfect for companies conducting clinical trials at numerous sites and companies lacking the facilities, controls and infrastructure to conduct supply chain activities and distribute products.

Our services include:
Supply Chain Management- component procurement to finished product distribution
Warehouse Inventory Management
Packaging & Kitting
Decontamination Processing
Loaner Kit Processing
Distribution

OFFSHORE MANUFACTURING SERVICES

As your business and market share grows, products mature - cost reduction becomes paramount to growing margins.  LSO can help with our Sister facility, a Maquilladora plant located a short distance away in Tijuana, MX.  With its close proximity and reduced labor rates, it offers an ideal path for lower cost manufacturing. 

INCUBATOR SERIVCES

Looking to launch your venture without the burden of establishing a manufacturing facility, LSO can help.  They offer office space in addition to clean room manufacturing space and support services.  With the ability to operate under their Quality System, you can focus on designing and manufacturing your device.  They are conveniently located about 20 miles from the Orange County Airport.  With their broad ranges of services and aggressive pricing for start-up operations, they challenge the need for companies to establish their own manufacturing operation.





Our Suppliers
ArcRev
Hart Enterprises
Phillips Precision Medicraft
Preferred Precision & Tools and Die