Our Certifications

Life Science Outsourcing is an FDA registered and ISO 13485:2003 certified full service Medical Device Contract Manufacturer. We maintain the following certificates as part of our quality system.

• FDA CDRH Registration: Contract Manufacturer, Contract Sterilizer

• State of California: Device Manufacturing License

• State of California: Drug Manufacturing License

• California Board of Pharmacy: Drug Wholesaler License

• International Standard ISO 13485:2003

• CMDCAS ISO 13485:2003

• International Standard I.S. EN ISO 13485:2012

• International Standard ISO 17665:2006 Moist Heat Sterilization

• ISTA Certified Package Testing Laboratory

• Japan Minister of Health: Medical Device Manufacturer, Sterile and Non Sterile Devices.

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.