Our Certifications

We maintain the following certificates as part of our quality system.

Our CertificationsRuben J. Osuna2020-08-26T16:43:37-07:00

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
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

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.