Life Science Outsourcing (LSO) is an FDA-registered, ISO 13485-certified medical device contract manufacturer with facilities in Brea, CA; Somersworth, NH; and Costa Rica — 12 cleanrooms (Class 5–8) across 125,000+ sq ft. We consolidate the regulated late-stage work so device companies ship compliant product faster, with fewer vendors and fewer surprises.
Services:
- Cleanroom assembly & kitting
- Packaging validation (ISO 11607)
- Sterilization validation (ISO 11135 EO, ISO 11137 gamma, ISO 17665 steam)
- Cleaning & decontamination
- Diagnostics consumable manufacturing (J-Pac Medical)
Who we work with:
- Mid-to-large OEMs consolidating vendors
- Startups launching their first FDA-cleared device
- Diagnostics companies scaling from 10K to 10M+ units
Subscribe for cleanroom tours, packaging and sterilization deep dives, and a look inside regulated medical device manufacturing.
→ lso-inc.com to request a quote.
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