Skip the infrastructure build. Launch your device faster.

No. When you manufacture through LSO, your device is produced in our FDA-registered, ISO 13485 certified facility. You'll need your own FDA establishment registration and device listing, but you don't need to build or register your own manufacturing facility. Many startups use LSO's infrastructure for their first product launch and only consider in-house manufacturing after they've reached significant commercial volume.

Cost depends on your device complexity, cleanroom class requirements, volume, and which services you need (assembly, packaging, sterilization, validation). We provide transparent line-item quoting after an initial assessment — no hidden fees or surprise charges. For most startups, outsourcing to LSO costs a fraction of what it would take to build your own cleanroom and quality system, which typically runs $2M+ and 12–18 months before you produce a single unit.

Typical startup engagements move from first call to validated production in 4–12 weeks, depending on device complexity and which services you need. If your device design is finalized and you have regulatory clearance, the timeline compresses. If you're still in development, we can support prototyping and DFM in parallel with your regulatory submission so manufacturing is ready when your clearance comes through.

That's fine — most startups start with what they need now and add services as they scale. You might start with cleanroom assembly and packaging validation, then add sterilization management later. Because everything is under one quality system, adding services doesn't require requalifying a new vendor. You're already in the system.

Most CMOs specialize in one thing — assembly, or packaging, or sterilization. LSO consolidates all of these under one FDA-registered facility and one ISO 13485 quality system. For startups, this means you deal with one vendor, one audit, and one point of accountability instead of coordinating three or four separate companies. It also means your device doesn't leave LSO's controlled environment between steps — reducing contamination risk and handoff errors.

We provide manufacturing-side documentation and guidance, not regulatory consulting. That means we deliver audit-ready DHRs, packaging validation reports (ISO 11607), sterilization validation data (ISO 11135/11137), and process documentation formatted for your 510(k), De Novo, or PMA submission. Many startups pair LSO's manufacturing documentation with a regulatory consultant who handles the submission strategy — we work alongside them to make sure the manufacturing sections are complete and defensible.

LSO operates 125,000+ sq ft across three facilities (California, New Hampshire, Costa Rica). Your validated processes transfer across locations without requalification, so scaling from startup volume to commercial production doesn't mean starting over with a new manufacturer. Many of the 820+ startups we've supported have grown from initial prototype runs into sustained commercial production with us.