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.

From day one LSO has exceeded our expectations. All the divisions we have worked with have been professional, knowledgeable, easily accessible and quickly responsive. The attention to detail and communication has been terrific. We are very happy we found LSO. They have met all our needs and then some!

Jeff

Director of Operations

Industry: Orthopedic

Divisions worked with: Medical Package Testing, Sterilization Validation Services

Posted at: 03-21-2018