Consolidate vendors. Eliminate handoffs. Gain capacity assurance.

Every handoff between vendors is a failure point — contamination risk, documentation gaps, miscommunication on specs. When your device stays in one controlled environment from assembly through sterilization, those failure points disappear. One quality system means one set of procedures, one CAPA process, and one team accountable for the entire chain of custody. Our OEM customers consistently report fewer nonconformances after consolidation.

We support multiple device lines across the same facilities under one quality system with device-specific procedures. Many OEMs start by consolidating one product line to validate the relationship, then expand to additional products over 6–12 months. Your quality agreement covers all products manufactured at LSO, so adding a new device line doesn't require a new supplier qualification — just a process-specific validation.

We use a phased approach: assessment of your current vendor structure and requirements, process transfer and validation at LSO, parallel production (running at both LSO and your current vendor simultaneously), then full cutover once quality and timeline targets are confirmed. There's no hard cutover on day one — the overlap period ensures supply continuity throughout the transition. Most single product line transitions take 3–4 months.

All three facilities operate under one ISO 13485 certified quality management system. Procedures, training programs, equipment qualification, and quality standards are identical across California, New Hampshire, and Costa Rica. Processes are validated to transfer between sites without requalification, which is what enables multi-site capacity scaling. One audit covers the entire system.

It depends on scope. A single product line consolidation typically takes 3–4 months from initial assessment to validated production at LSO. Full portfolio consolidation across multiple product lines is usually 6–12 months, phased to minimize disruption. The initial assessment takes 1–2 weeks and gives you a detailed timeline, cost comparison, and transition plan before you commit to anything.

One audit covers the quality system since all facilities operate under one QMS. Auditing any one site gives you confidence in the procedures and controls at all three — they're identical. Most OEM customers conduct a thorough initial audit of the primary receiving facility for their product line, with a lighter documentary review of the other sites. Annual surveillance audits follow the same pattern.

Consolidation eliminates coordination overhead between multiple vendors, duplicate quality management costs, multi-vendor logistics, and the hidden cost of managing quality escapes at handoffs. Direct manufacturing costs depend on your specific volume, device complexity, and cleanroom requirements. We provide transparent line-item quoting so you can compare total cost of ownership against your current multi-vendor structure — not just unit price, but the full picture including quality management, logistics, and audit costs.