Life Science Outsourcing Inc.

Company Headquarters

830 Challenger Street
Brea, CA 92821
United States

View Phone No.

Company Description

Vital Statistics:
Year Founded: 1997
Number of Facilities: 1
Certifications: ISO 13485, ISO 17665, ISO 11135, FDA CDRH Registration: Contract Manufacturer, Contract Sterilizer, FDA CDER Drug Sterilization Registration, State of California Device and Drug Manufacturing License and Drug Wholesaler License, ISTA Certified Package Testing Laboratory, Japan Minister of Health: Medical Device Manufacturer, Sterile and Non-Sterile Devices.

Who We Are:
We are an FDA-registered and ISO 13485-certified organization with services and capabilities spanning the complete product life-cycle. From turnkey manufacturing, testing, validation, and sterilization to decontamination, fulfillment, and distribution. LSO has partnered with more than 1,400 medical device innovators to streamline production and navigate complex regulatory requirements.

Major Markets:
LSO has extensive industry expertise and proven results across fast-moving sectors such as Orthopedic, Trauma, Cardiovascular, Cardiac Rhythm Management, Respiratory Care, Neurovascular, Neurostimulation, Gastrointestinal / OBGYN, In-Vitro Diagnostics, Dental, Drug Delivery & Fluid Management, and In-Vitro Diagnostics. We combine detailed industry-specific techniques and approaches with broad medical device manufacturing best practices to accelerate time to market and reduce costs.

Services Offered:
For 25 years LSO has provided our partners with Innovative assembly, packaging and sterilization services. Our Forward-thinking Manufacturing Solutions include ISO Class 5 / 6 / 7 Cleanrooms, complex assembly, catheter assembly, Bonding Processes, Electromechanical Assembly, Combination Products, and Ultrasonic / Laser welding. We help you accelerate your time to market by proving word-class Process Validation, Manufacturing Procedures, Packaging Development, Complete Documentation Packages, Engineering Services, and Medical Device Incubator Services (MDIS).

LSO also provides contract sterilization and validation services for single-use and reusable devices with In-House Steam and EtO sterilization, Biological Indicator (BI) Testing, Contracted Gamma and e-beam, and Contracted Large Chamber EtO capabilities.