# Certifications

> Discover Life Science Outsourcing's certifications as a top-tier medical device assembly Contract Manufacturing Organization, showcasing our FDA-registered and ISO 13485-certified commitment to quality and excellence.

Source: https://lso-inc.com/certifications/

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![Certifications](https://lso-inc.com/api/media/file/Certifications.webp)

FDA-Registered

Manufacturing Facility

ISO 13485

Certified Quality System

12 Cleanrooms

Class 5–8

125,000+ Sq Ft

Regulated Manufacturing

3 Facilities

CA | NH | Costa Rica

ISO 17025

Accredited Packaging Lab

## Life Science Outsourcing’s Certifications

-   [International Standard ISO 13485:2016 (Brea, CA)](https://lso-inc.com/media/MD19.4297-IS-EN-ISO-13485-2016-Certificate-6-30-30.pdf)
-   [International Standard ISO 13485:2016 (Somersworth, NH)](https://lso-inc.com/media/LSO-East_ISO-13485_11-03-26.pdf)
-   [FDA CDRH Registration: Contract Manufacturer, Contract Sterilizer](https://lso-inc.com/media/LSO_FDA-Registration-Contract-Manufacture-2031093_12-31-29.pdf)
-   [FDA CDRH Registration: Contract Manufacturer (Somersworth, NH)](https://lso-inc.com/media/LSO-East_FDA-Registration-Contract-Manufacturer_12-31-26.pdf)
-   [State of California: Device Manufacturing License](https://lso-inc.com/media/CA-Medical-Device-Manufacturing-License-Exp.-01-20-33.pdf)
-   [International Standard ISO 17665-1:2006 Moist Heat Sterilization](https://lso-inc.com/media/MD19.4297-IS-EN-ISO-13485-2016-Certificate-6-30-30.pdf)
-   [International Standard ISO 11135:2014 Contract Ethylene Oxide Sterilization and Validation Services](https://lso-inc.com/media/MD19.4297-IS-EN-ISO-13485-2016-Certificate-6-30-30.pdf)
-   [CDER Drug Sterilization Registration](https://lso-inc.com/media/FDA-CDER-Drug-Sterilization-Registration_12-31-29.pdf)
-   [State of California: Drug Manufacturing License](https://lso-inc.com/media/CA-Drug-Manufacturing-License-Exp.-05-13-29.pdf)
-   [Japan Minister of Health: Medical Device Manufacturer, Sterile and Non Sterile Devices](https://lso-inc.com/media/LSO_CERT_JAPAN_04-14-2035.pdf)
-   [ISTA Certified Package Testing Laboratory](https://lso-inc.com/media/ISTA-Certified-Testing-Laboratory-Licenses-7-1-2032.pdf)

#### [About LSO](https://lso-inc.com/company/)

![LSO Quality Assurance in Action: Cleanroom Supervisor Ensures Medical Device Assembly Excellence](https://lso-inc.com/api/media/file/protocol-thumb-3.jpg)

Life Science Outsourcing has an unwavering commitment to quality and evolving industry requirements.

As an FDA-registered and ISO 13485-certified contract manufacturing organization, we excel in medical device assembly, packaging, sterilization, and diagnostics (wet reagent packaging) for the life science sector. Our end-to-end services, coupled with extensive regulatory knowledge, ensure streamlined processes for accelerated go-to-market launches. Explore our range of certifications that underline our continued commitment to superior quality management and risk mitigation in the medical device assembly field.

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