# LSO | FDA-Registered Medical Device Contract Manufacturing > Assembly, packaging validation, sterilization, and cleaning under one FDA-registered, ISO 13485 certified quality system. 25+ years. 12 cleanrooms. 3 facilities. Source: https://lso-inc.com/ --- ![LSO cleanroom facility — FDA-registered medical device manufacturing](https://lso-inc.com/images/hero-cleanroom.jpg) # The regulated finish line for medical devices Assembly, packaging, validation, and sterilization — consolidated under one FDA-registered, ISO 13485 certified quality system. 25+ years. 12 cleanrooms. 125,000+ sq ft across California, New Hampshire, and Costa Rica. [Request a Quote](https://lso-inc.com/contact/) [See How We Work](https://lso-inc.com/#choose-your-path) 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 ## Choose Your Path Different companies, different needs. Start with the path that matches where you are. [ Launching Your First Device? ### Startups Access cleanroom infrastructure, quality systems, and regulatory guidance without building your own. 820+ startups launched. See the Startup Path](https://lso-inc.com/start-here/startups/)[ Scaling or Consolidating Vendors? ### OEMs Reduce handoffs, audit exposure, and supplier risk with a single FDA-registered partner across assembly, packaging, and sterilization. See the OEM Path](https://lso-inc.com/start-here/oem/)[ Scaling Diagnostics Consumables? ### Diagnostics Precision reagent packaging, cartridge assembly, and controlled-environment manufacturing for IVD and POC devices. See the Diagnostics Path](https://lso-inc.com/start-here/diagnostics/) ## Consolidated Solutions Under One Roof Assembly, packaging, validation, and sterilization — without the vendor handoffs. ### Assembly & Kitting Cleanroom assembly, kitting, and packaging under one quality system. Request a Quote](https://lso-inc.com/solutions/assembly-kitting/)[ ### Packaging Validation ISO 11607-compliant packaging development, testing, and validation. Get a Validation Plan](https://lso-inc.com/solutions/packaging-validation/)[ ### Sterilization & Validation EO, gamma, and e-beam sterilization with full validation support. Book a Consult](https://lso-inc.com/solutions/sterilization-validation/)[ ### Cleaning & Decontamination Loaner kit processing, surgical instrument cleaning, and reprocessing. Get an Assessment](https://lso-inc.com/solutions/cleaning-decontamination/)[ ### Diagnostics Manufacturing Reagent packaging, cartridge assembly, and IVD consumable production. Request an Assessment](https://lso-inc.com/solutions/diagnostics-manufacturing/) ## One Partner Replaces Five Vendors Every vendor handoff is a chance for delays, quality gaps, and finger-pointing. LSO consolidates the entire regulated finish line under one quality system, one point of contact, and one predictable timeline. ### Typical Multi-Vendor Path 1 Assemblerhandoff risk 2 Packagerhandoff risk 3 Validatorhandoff risk 4 Sterilizerhandoff risk 5 Distributor 4 handoffs = 4 points of failure, 4 quality systems, 4 audits ### The LSO Path Assembly Packaging Validation Sterilization Distribution 1 quality system, 1 point of contact, 0 handoffs 50% Fewer vendor audits 30% Faster time to market Quality system to validate ## Built on 25 Years of Regulated Manufacturing When your device reaches LSO, it enters a system built over two decades of FDA oversight, ISO audits, and thousands of product launches. 25+ Years FDA-Registered 820+ Product Launches Supported $4B+ Client Acquisition Value Created 12 Cleanrooms, Class 5–8 ### What Consolidation Looks Like in Practice Consolidated assembly, packaging validation, and EO sterilization for a Class II sterile orthopedic device — reducing their vendor count from four to one and cutting 14 weeks from their launch timeline. Orthopedic OEM, Class II Sterile Device Supported a first-time device startup from prototype packaging through FDA submission — providing cleanroom assembly, ISO 11607 validation, and sterilization under a single quality system. Medical Device Startup, Class II Certifications & Standards FDA RegisteredISO 13485:2016ISO 11607ISO 11135ISO 11137ISO 17665ISO 1099321 CFR 820 ## Ready to simplify your supply chain? One partner for assembly, packaging, validation, and sterilization. Tell us about your device and we'll outline a path forward within one business day. [Request a Quote](https://lso-inc.com/contact/) [Call (714) 672-1090](tel:+17146721090)