Our Certifications

Life Science Outsourcing is an FDA registered and ISO 13485 certified full service Medical Device Contract Manufacturer. We maintain the following certificates as part of our quality system.

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FDA CDRH Registration: Contract Manufacturer, Contract Sterilizer
CDER Drug Sterilization Registration
State of California: Device Manufacturing License
State of California: Drug Manufacturing License
International Standard ISO 13485:2016
International Standard ISO 17665-1:2006 Moist Heat Sterilization
International Standard ISO 11135:2014 Contract Ethylene Oxide Sterilization and Validation Services
Japan Minister of Health: Medical Device Manufacturer, Sterile and Non Sterile Devices.
ISTA Certified Package Testing Laboratory
California Board of Pharmacy: Drug Wholesaler License
California Water Boards: General Permit to Discharge Storm Water

If you would like more information regarding LSO’s Certifications, Mission and Values, Facility, Resources and Services, please sends us an email via our contact us page.