# Medical Device Vendor Consolidation | One CMO for Assembly to Sterilization | LSO > Consolidate medical device assembly, packaging, validation, and sterilization under one FDA-registered, ISO 13485 certified CMO. Three facilities, one quality system, predictable timelines. Reduce vendor risk with LSO. Source: https://lso-inc.com/start-here/oem/ --- # Consolidate vendors. Eliminate handoffs. Gain capacity assurance. One FDA-registered partner for assembly, packaging, validation, and sterilization — across three facilities with one quality system. [Request a Consolidation Assessment](https://lso-inc.com/start-here/oem/#oem-form) ![OEMs](https://lso-inc.com/api/media/file/vendor.webp) 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 Managing four or five vendors for assembly, packaging, validation, and sterilization creates compounding risk: quality escapes at handoffs, audit burden on your QA team, and timelines that slip every time a vendor drops the ball. You need predictability — not more vendor meetings. ## The Multi-Vendor Problem ### Supplier quality escapes Every vendor handoff is a failure point. When assembly, packaging, and sterilization happen at different facilities with different quality systems, nonconformances multiply. ### Audit burden Four vendors means four supplier audits, four quality agreements, four corrective action processes. Your QA team is stretched thin managing the patchwork. ### Capacity constraints Volume spikes expose single-site risk. When your primary assembly vendor can't scale, you scramble — and your customers feel it. ### Missed delivery windows Coordinating handoffs between assembly, packaging, and sterilization vendors adds weeks. Each delay compounds downstream — and your customer commitments slip. ## What Consolidation Does to Your Timeline Multi-vendor coordination adds weeks at every handoff. With LSO, your device moves through a continuous process — no shipping between vendors, no waiting for incoming inspection, no redundant quality releases. Multi-Vendor Path The LSO Path Assembly 2–3 weeks Handoff delay Ship to packager + incoming QC ⚠ 1–2 weeks lost Packaging & validation 3–4 weeks Ship to sterilizer + incoming QC Sterilization Ship to warehouse ⚠ 1 week lost Release & ship 1 week 10–15 weeks Up to 6 weeks lost to inter-vendor coordination 8–11 weeks Zero handoffs. Same facility. Same quality system. ## The Consolidation Advantage ### One Quality System Assembly, packaging, validation, and sterilization under one ISO 13485 certified quality system. One audit, one quality agreement, one CAPA process. ### Multi-Site Capacity California, New Hampshire, and Costa Rica. If demand spikes or a facility has an issue, your supply doesn't stop. Qualified processes transfer across sites. ### 12 Cleanrooms (Class 5–8) 125,000+ sq ft of FDA-registered manufacturing space with cleanrooms matched to your device classification. Including Class 7 dry room for bioabsorbables. ### Predictable Timelines No inter-vendor coordination delays. Assembly flows directly to packaging, validation, and sterilization — under one roof, one schedule. ### Reduced Audit Burden Replace four supplier audits with one. Your QA team spends time on product quality, not vendor management. ### Full Traceability Device history records, assembly records, and validation documentation in one system. Complete chain of custody from component receipt to sterilized finished goods. ## Infrastructure You Can Verify 25+ Years FDA-registered 125K+ Sq ft regulated manufacturing 3 Facilities (CA, NH, Costa Rica) 12 Cleanrooms, Class 5–8 We consolidated assembly, packaging validation, and EO sterilization under LSO — went from four vendors to one and cut 14 weeks from our launch timeline. Orthopedic OEM, Class II Sterile Device ## Solutions for OEMs Explore the specific capabilities you can consolidate under one partner. [Assembly & KittingCleanroom assembly with multi-site capacity](https://lso-inc.com/solutions/assembly-kitting/) [Packaging ValidationISO 11607 from protocol design to production](https://lso-inc.com/solutions/packaging-validation/) [Sterilization & ValidationEO, gamma, and e-beam sterilization management](https://lso-inc.com/solutions/sterilization-validation/) [Cleaning & DecontaminationLoaner kit and reusable instrument processing](https://lso-inc.com/solutions/cleaning-decontamination/) [Diagnostics ManufacturingPrecision diagnostics consumables at scale](https://lso-inc.com/solutions/diagnostics-manufacturing/) ## Assess your consolidation opportunity Tell us about your consolidation goals. A manufacturing sales engineer will assess your requirements and reach out within one business day. ## What Happens Next ### Who A manufacturing sales engineer with consolidation and multi-site expertise ### When Within one business day of your submission ### About Current vendor structure, volume forecasts, quality requirements, and consolidation goals ## Frequently Asked Questions How does consolidating vendors actually reduce risk? 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. Can you handle our full device portfolio or just one product line? 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. What does the transition look like from our current vendors? 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. How do you maintain quality consistency across three facilities? 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. What's the typical timeline for vendor consolidation? 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. Do we need to audit all three facilities? 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. Will consolidation actually reduce our costs? 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.