Certifications
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 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 unwavering commitment to superior quality management and risk mitigation in the medical device assembly field.
Life Science Outsourcing’s Certifications
- International Standard ISO 13485:2016
- International Standard ISO 13485:2016 (LSO East)
- FDA CDRH Registration: Contract Manufacturer, Contract Sterilizer
- FDA CDRH Registration: Contract Manufacturer (LSO East)
- State of California: Device Manufacturing License
- International Standard ISO 17665-1:2006 Moist Heat Sterilization
- International Standard ISO 11135:2014 Contract Ethylene Oxide Sterilization and Validation Services
- CDER Drug Sterilization Registration
- State of California: Drug Manufacturing License
- Japan Minister of Health: Medical Device Manufacturer, Sterile and Non Sterile Devices
- ISTA Certified Package Testing Laboratory
One-Stop Shop
Life Science Outsourcing is an FDA-registered and ISO 13485-certified, performance-driven Contract Manufacturing Organization focused on assembly, packaging, sterilization, and diagnostics (wet reagent packaging). Our unique business model emphasizes in-house, end-to-end process and service offerings, coupled with deep regulatory knowledge. This provides the agility and flexibility necessary to accelerate go-to-market launches, while standardizing supply chain and mitigating risk.
