# Medical Device Contract Assembly & Kitting — Class 5–8 Cleanroom > Scale cleanroom assembly without building your own infrastructure. Class 5–8 cleanrooms, precision kitting, and multi-site capacity under one FDA-registered, ISO 13485 certified quality system. Source: https://lso-inc.com/solutions/assembly-kitting/ --- # Medical device contract assembly and kitting — scale without building your own cleanroom Class 5, Class 7, and Class 8 cleanroom assembly, precision kitting, and multi-site capacity under one ISO 13485 quality system [Request an Assembly & Kitting Quote](https://lso-inc.com/solutions/assembly-kitting/#intake-form) [See Our Cleanrooms](https://lso-inc.com/facilities-equipment-2/) ![Cleanroom assembly line](https://lso-inc.com/api/media/file/Cleanroomassemblyline.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 Scaling medical device contract assembly without internal cleanroom infrastructure is expensive and slow. You either invest millions in equipment and facilities, or juggle multiple vendors and risk quality escapes at every handoff. Vendor consolidation under one ISO 13485 quality system eliminates redundant audits, simplifies supply chain risk, and removes the handoffs where most failures happen — while your device launch date stays on schedule. ## Class 5–8 Cleanroom Assembly Capabilities ### Class 5–8 Cleanroom Assembly High-precision Class 5, Class 7, and Class 8 cleanroom assembly environments matched to your device classification — from implantables to diagnostics consumables. One ISO 13485 contract assembly quality system replaces vendor patchwork, meaning fewer audits and simpler compliance. ### Precision Kitting Complete device system kitting that reduces vendor touchpoints and ensures every component arrives together, validated, and documented. ### Bioabsorbable Processing Specialized solvent scouring and polymer processing for bioabsorbable and implantable devices — including Class 7 dry room access. A capability most CMOs lack. ### Multi-Site Capacity & Redundancy Three facilities across California, New Hampshire, and Costa Rica. If demand spikes or a site goes down, your supply doesn't stop. Qualified processes transfer across locations so you scale without revalidating. ### Audit-Ready Documentation Complete device history records, batch traceability, and 21 CFR 820-aligned assembly documentation structured for FDA inspection or customer audit. Your QA team reviews our DHRs, not chases them. ## How It Works 1 ### Discovery Call 30-minute call with a manufacturing engineer to understand your device, volume, complexity, and timeline. 2 ### Facility & DFM Assessment Review CAD and BOM, identify the right cleanroom class, and flag any assembly considerations. 3 ### Quote & Agreement Pricing based on volume, cleanroom class, and setup labor. No surprises — transparent line-item quoting. 4 ### Setup & Validation Kitting jig design, procedure validation, and first-piece QC. 5 ### Production & Ongoing Support Scheduled production runs, real-time status updates, and regular quality review meetings. ## When You Need Contract Assembly New product launch requiring immediate cleanroom access — no time to build internally Scaling from prototype to production volume and current capacity is maxed Vendor consolidation: reducing supply chain risk and audit burden across multiple assembly partners 21 CFR 820 audit findings or quality escapes at your current assembly vendor Bioabsorbable or implantable devices requiring specialized equipment and environment ## Explore Further [Cleanroom Assembly for Medical DevicesISO 13485 CMO capabilities and cleanroom specs](https://lso-inc.com/cleanroom-assembly-medical-devices/) [Assembly, Packaging & KittingFull-service assembly and kitting overview](https://lso-inc.com/assembly-packaging-kitting/) [Biomaterial & Synthetic Implantable ManufacturingSpecialized bioabsorbable polymer processing](https://lso-inc.com/biomaterial-synthetic-implantables/) [OEM PathScaling or consolidating vendors — start here](https://lso-inc.com/start-here/oem/) ## Get a quote for your assembly and kitting needs Tell us about your device, volume, and timeline. Our manufacturing engineering team will assess your cleanroom and kitting requirements within 48 hours. Best fit for Class II/III medical devices requiring controlled-environment assembly. ## What Happens Next ### Who A manufacturing sales engineer with cleanroom assembly expertise ### When Within one business day of your submission ### About Device details, volume forecast, timeline, and facility preference (CA, NH, or Costa Rica) ## Frequently Asked Questions What cleanroom class do I need for my device? It depends on your device classification and the nature of the assembly. Class II sterile devices typically require Class 7 or Class 8 environments, while implantables and devices with direct tissue contact often need Class 5 or Class 6. During our discovery call, we'll review your device specs and recommend the appropriate cleanroom class — we operate Class 5 through Class 8 across all three facilities. Is LSO an FDA-registered contract assembler? Yes. LSO is FDA-registered and ISO 13485 certified across all three facilities (California, New Hampshire, and Costa Rica). Our quality system is built around 21 CFR 820, and our assembly documentation is structured to pass FDA inspection or customer audit. We can provide our registration numbers and current certifications under NDA. How quickly can you ramp to production volume? From first contact to validated production typically takes 6–10 weeks, depending on device complexity and cleanroom class. Setup and validation (jig design, procedure validation, first-piece QC) is usually 2–4 weeks after quoting. If you need surge capacity, our multi-site footprint across California, New Hampshire, and Costa Rica means we can shift volume between facilities without requalifying. Can you handle bioabsorbable materials? Yes — this is one of our specialized capabilities. We operate a Class 7 dry room and have validated solvent scouring processes for bioabsorbable and implantable polymers. Most contract manufacturers don't have the controlled-humidity environment or the material handling expertise that bioabsorbables require. If your device uses PLA, PGA, PLGA, or similar polymers, we can process it. What documentation do I receive with each production run? Every production run includes complete device history records (DHRs), batch traceability records, in-process inspection data, and final release documentation. Everything is structured for FDA inspection or customer audit — your QA team can review our records without chasing them down. We also maintain full lot traceability from incoming components through finished goods. Do I need to be on-site during setup and validation? It's not required, but we recommend a visit during the DFM assessment and first-article inspection. Many customers send their manufacturing or quality engineer for 1–2 days during setup. After validation, production runs are managed remotely with real-time status updates and scheduled quality review meetings. How do you manage quality across multiple facilities? All three facilities operate under one ISO 13485 certified quality management system. Procedures, training, and quality standards are identical across California, New Hampshire, and Costa Rica. This means one audit covers all locations, and processes transfer between sites without revalidation. Your quality team deals with one QMS, not three. What happens if there is a quality escape? We follow a formal CAPA process for any nonconformance. Root cause analysis begins within 24 hours, with containment actions implemented immediately. You receive a full investigation report with corrective and preventive actions, and we track effectiveness over subsequent production runs. Our goal is to prevent recurrence, not just fix the symptom.