• Life Science Outsourcing, Inc.


    830 Challenger St
    Brea, CA
    92821
    United States
  • 125,000 square feet, 3
  • (714) 672-1090
  • Founded in 1997
  • Operating in North America
  • Visit Website

  • Senior Manager, Information Technology

markChanges saved

  • Cases & Trays
  • Packaging
  • Regulatory/Quality Assurance
  • Sterilization
  • Surface Preparation/Treatments
  • Testing
Innovative Medical Device Assembly, Packaging and Sterilization.
About Us

Life Science Outsourcing is a performance-driven CMO. Our unique model leverages in house end-to-end solutions and service offerings, coupled with deep regulatory knowledge. This allows us to provide the agility and flexibility that customers need to accelerate their go to market launches, while streamlining their supply chain and mitigating risk. Our core services include: assembly, packaging, medical package testing, sterilization, reagent packaging & design, thermoforming, and resorbables.

Our Capabilities
Medical Device Assembly

Assembly, Packaging & Kitting

Life Science Outsourcing provides comprehensive assembly, packaging, and kitting solutions tailored to the unique needs of medical device manufacturers. We streamline the process from component assembly to sterile and non-sterile packaging, ensuring compliance with regulatory requirements and optimizing supply chain efficiency.

Complex Assembly

Life Science Outsourcing specializes in complex medical device assembly, ensuring high-precision component integration, cleanroom-controlled processes, and compliance with industry regulations.

Labeling

Life Science Outsourcing provides medical device labeling solutions that ensure accuracy, compliance, and traceability for regulatory approval and end-user safety.

Supply Chain Management

Life Science Outsourcing provides end-to-end supply chain solutions tailored to the medical device industry, ensuring seamless procurement, production, and distribution.

Cleaning & Passivation

Life Science Outsourcing offers precision cleaning and passivation services to remove contaminants and enhance corrosion resistance for medical devices.

Medical Device Assembly

Assembly, Packaging & Kitting

Life Science Outsourcing provides comprehensive assembly, packaging, and kitting solutions tailored to the unique needs of medical device manufacturers. We streamline the process from component assembly to sterile and non-sterile packaging, ensuring compliance with regulatory requirements and optimizing supply chain efficiency.

Complex Assembly

Life Science Outsourcing specializes in complex medical device assembly, ensuring high-precision component integration, cleanroom-controlled processes, and compliance with industry regulations.

Labeling

Life Science Outsourcing provides medical device labeling solutions that ensure accuracy, compliance, and traceability for regulatory approval and end-user safety.

Supply Chain Management

Life Science Outsourcing provides end-to-end supply chain solutions tailored to the medical device industry, ensuring seamless procurement, production, and distribution.

Cleaning & Passivation

Life Science Outsourcing offers precision cleaning and passivation services to remove contaminants and enhance corrosion resistance for medical devices.

Medical Package Testing

We are an ISTA certified packaging test lab (ID Number ST-2339). MPT is devoted to the validation, testing and design of packaging for medical device manufacturers, pharmaceutical companies, biotech companies, and the diagnostic industry.

Medical Package Testing (MPT) is a division of Life Science Outsourcing, Inc. (LSO), which is an ISTA-certified packaging test lab (ID Number ST-2339). MPT is devoted to the validation, testing, and design of packaging for medical device manufacturers, pharmaceutical companies, biotech companies, and the diagnostic industry. Our 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.

Medical Package Testing

We are an ISTA certified packaging test lab (ID Number ST-2339). MPT is devoted to the validation, testing and design of packaging for medical device manufacturers, pharmaceutical companies, biotech companies, and the diagnostic industry.

Medical Package Testing (MPT) is a division of Life Science Outsourcing, Inc. (LSO), which is an ISTA-certified packaging test lab (ID Number ST-2339). MPT is devoted to the validation, testing, and design of packaging for medical device manufacturers, pharmaceutical companies, biotech companies, and the diagnostic industry. Our 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.

Sterilization and Validation

Ethylene Oxide (EtO/EO)
Sterilization

Small-batch, quick-turn, in-house EtO sterilization delivers rapid processing in as little as 5-7 days (24-hour expedited option available) without compromising quality or compliance.

In-House Steam Sterilization

Life Science Outsourcing is the largest contract steam sterilization provider on the West Coast. Get started on your project today.

In-House Steam Sterilization for Drug Delivery Components

LSO offers in-house, CDER-certified contract steam sterilization for drug delivery components like vials, syringes, and closures. Improve compliance and reduce delays with on-site processing and full regulatory alignment.

Gamma and E-Beam sterilization and validation

Life Science Outsourcing provides sterilization services, as well as validation services, for gamma and E-Beam.

 

Sterilization and Validation

Ethylene Oxide (EtO/EO)
Sterilization

Small-batch, quick-turn, in-house EtO sterilization delivers rapid processing in as little as 5-7 days (24-hour expedited option available) without compromising quality or compliance.

In-House Steam Sterilization

Life Science Outsourcing is the largest contract steam sterilization provider on the West Coast. Get started on your project today.

In-House Steam Sterilization for Drug Delivery Components

LSO offers in-house, CDER-certified contract steam sterilization for drug delivery components like vials, syringes, and closures. Improve compliance and reduce delays with on-site processing and full regulatory alignment.

Gamma and E-Beam sterilization and validation

Life Science Outsourcing provides sterilization services, as well as validation services, for gamma and E-Beam.

 

Cleaning and Decontamination

Reusable Device Processing

Life Science Outsourcing has proven expertise in helping medical device manufacturers navigate the decontamination process, enhance efficiencies, and meet all regulatory requirements.

Single Use Device Reprocessing

Life Science Outsourcing provides comprehensive single-use device (SUD) reprocessing services, ensuring safety, compliance, and cost-effectiveness for healthcare facilities and medical device manufacturers.

Loaner Kit Processing and Program Management

Loaner kit processing is an essential operational requirement for original equipment manufacturers that support surgical procedures. Managing loaner kits internally consumes time, labor, and capital that would otherwise be directed toward core manufacturing and commercialization activities. Outsourcing loaner kit processing to LSO’s Sterilization Validation Services (SVS) enables OEMs to maintain consistent quality while achieving cost savings across labor, processing, inventory management, distribution, and turnaround time.

Field Return Device Cleaning and Decontamination

Life Science Outsourcing offers specialized cleaning and decontamination services for field-returned medical devices, ensuring they are restored to safe and functional conditions.

Quality Inspection

Life Science Outsourcing can replicate and improve upon your internal loaner kit inspection and returns inspection processes, further protecting your company and your patients.

Cleaning and Decontamination

Reusable Device Processing

Life Science Outsourcing has proven expertise in helping medical device manufacturers navigate the decontamination process, enhance efficiencies, and meet all regulatory requirements.

Single Use Device Reprocessing

Life Science Outsourcing provides comprehensive single-use device (SUD) reprocessing services, ensuring safety, compliance, and cost-effectiveness for healthcare facilities and medical device manufacturers.

Loaner Kit Processing and Program Management

Loaner kit processing is an essential operational requirement for original equipment manufacturers that support surgical procedures. Managing loaner kits internally consumes time, labor, and capital that would otherwise be directed toward core manufacturing and commercialization activities. Outsourcing loaner kit processing to LSO’s Sterilization Validation Services (SVS) enables OEMs to maintain consistent quality while achieving cost savings across labor, processing, inventory management, distribution, and turnaround time.

Field Return Device Cleaning and Decontamination

Life Science Outsourcing offers specialized cleaning and decontamination services for field-returned medical devices, ensuring they are restored to safe and functional conditions.

Quality Inspection

Life Science Outsourcing can replicate and improve upon your internal loaner kit inspection and returns inspection processes, further protecting your company and your patients.

Fulfillment and Distribution

Finished Goods Management

Life Science Outsourcing logistics solutions finished goods management can ensure your on-time deliveries.

Order Processing

Life Science Outsourcing seeks to enhance effectiveness and efficiency with streamlined order processing to deliver greater value for our customers.

Warehousing

Life Science Outsourcing’s FDA-certified fulfillment warehouse has over 30,000 square feet of secure storage space, and our team has the experience and expertise to provide cost-efficient and effective storage solutions.

Quality Assurance

Life Science Outsourcing’s quality assurance solutions were devised by experienced professionals who have a deep understanding of the supply chain management process.

Shipping and Distribution

Life Science Outsourcing’s shipping and distribution solutions begin with the right people and proper understanding of quality, requirements, and cost efficiency.

Fulfillment and Distribution

Finished Goods Management

Life Science Outsourcing logistics solutions finished goods management can ensure your on-time deliveries.

Order Processing

Life Science Outsourcing seeks to enhance effectiveness and efficiency with streamlined order processing to deliver greater value for our customers.

Warehousing

Life Science Outsourcing’s FDA-certified fulfillment warehouse has over 30,000 square feet of secure storage space, and our team has the experience and expertise to provide cost-efficient and effective storage solutions.

Quality Assurance

Life Science Outsourcing’s quality assurance solutions were devised by experienced professionals who have a deep understanding of the supply chain management process.

Shipping and Distribution

Life Science Outsourcing’s shipping and distribution solutions begin with the right people and proper understanding of quality, requirements, and cost efficiency.

Medical Device Incubator Service

Our medical device incubator services offer comprehensive support for medical device development, including facility utilization, quality management guidance, FDA registration assistance, clinical and R&D builds, full traceability, and product packaging and validation support

 

Cleanroom Rental for Startups and Growing OEMs

Startups creating new medical devices and growing commercial OEMs requiring surge capacity can rent our Class 7 (Class 5 pharma) cleanroom space and equipment to build prototypes, small lots, or scale production, all while benefitting from LSO engineering staff support.

Quality Management System Coverage

Life Science Outsourcing provides robust quality management system coverage to meet our clients’ various medical device needs.

Device Design History File (DHF) Development

Life Science Outsourcing has the resources to assist medical device manufacturers with design DHF, including conditions, tasks, and activities.

Unique Device Identification (UDI) System Implementation

Life Science Outsourcing can help medical device manufacturers meet UDI system labeling and bar code requirements.

Medical Device Incubator Service

Our medical device incubator services offer comprehensive support for medical device development, including facility utilization, quality management guidance, FDA registration assistance, clinical and R&D builds, full traceability, and product packaging and validation support

 

Cleanroom Rental for Startups and Growing OEMs

Startups creating new medical devices and growing commercial OEMs requiring surge capacity can rent our Class 7 (Class 5 pharma) cleanroom space and equipment to build prototypes, small lots, or scale production, all while benefitting from LSO engineering staff support.

Quality Management System Coverage

Life Science Outsourcing provides robust quality management system coverage to meet our clients’ various medical device needs.

Device Design History File (DHF) Development

Life Science Outsourcing has the resources to assist medical device manufacturers with design DHF, including conditions, tasks, and activities.

Unique Device Identification (UDI) System Implementation

Life Science Outsourcing can help medical device manufacturers meet UDI system labeling and bar code requirements.

Product catalogs and brochures
Orthopedic Solutions.pdf3.2MB
Facilities
LSO West
830 Challenger Street
Brea, California 92821
United States
714-672-1090
LSO East
25 Centre Road
Somersworth, New Hampshire 03878
603-692-9955
Is this your company? or contact us us to make updates.

CONTACT BONEZONE

 

CONTACT BONEZONE