# Diagnostics Manufacturing Services > Life Science Outsourcing provides end-to-end diagnostics manufacturing services, from assembly and packaging to sterilization, helping you bring products to market faster. Source: https://lso-inc.com/diagnostics-manufacturing-services/ --- # Medical device assembly with FDA compliance certainty Skip the cleanroom buildout delays and regulatory headaches. Get your devices assembled to commercial standards in our ISO 13485 facilities. [Get an Assembly Quote](https://lso-inc.com/contact/) [Tour Our Cleanrooms](https://lso-inc.com/facilities-equipment/) ![Medical device assembly with FDA compliance certainty](https://lso-inc.com/api/media/file/Medicaldeviceassembly.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 Building your own cleanroom means 12-18 months of delays, $500K+ in capital costs, and regulatory validation headaches that derail product launches. Medical device manufacturers need assembly capacity that scales with demand while maintaining the quality standards required for FDA submission. LSO's medical device assembly services eliminate these bottlenecks with 12 validated cleanrooms (Class 5-8) across three facilities. We've assembled devices for 820+ successful product launches, handling everything from simple component kitting to complex multi-step assembly with full traceability documentation. ## Assembly Capabilities That Scale With Your Launch ### Complex Multi-Component Assembly Handle intricate device assembly with up to 50+ components per unit, including sub-assemblies, adhesive bonding, and precision alignment. ### Cleanroom Assembly (Class 5-8) 12 validated cleanrooms with environmental monitoring and particle counting to meet the most stringent sterility requirements. ### Automated & Manual Assembly Lines Flexible production lines that adapt to your volume needs, from prototype runs to commercial-scale manufacturing. ### Kitting & Packaging Integration Complete device kitting with sterile packaging, labeling, and serialization for ready-to-ship finished goods. ### Quality Documentation Full traceability with batch records, component genealogy, and statistical process control data for regulatory submissions. ### Rapid Scale-Up Support Transition from R&D quantities to commercial volumes without facility changes or process transfers. ## Your Device Assembly Process 1 ### Assembly Process Design Our engineers review your device design, create assembly work instructions, and establish quality checkpoints for optimal manufacturability. 2 ### Cleanroom Setup & Validation We configure the appropriate cleanroom environment, validate all equipment, and establish environmental monitoring protocols. 3 ### Component Receiving & Inspection Incoming materials are received, inspected per your specifications, and stored in controlled conditions with full traceability. 4 ### Assembly & In-Process Testing Trained technicians assemble your devices following validated procedures with real-time quality monitoring at each step. 5 ### Final Inspection & Packaging Completed devices undergo final inspection, packaging in sterile barriers, and labeling before shipment to your distribution network. ## Is LSO Assembly Right for Your Device? ### Best For - Devices requiring Class 5-8 cleanroom assembly - Multi-component products with 10-50+ parts - Products needing FDA-compliant documentation - Startups avoiding cleanroom capital costs - OEMs needing rapid scale-up capability - Devices with complex quality requirements ### Not a Fit For - Simple, single-component products - Devices assembled in non-controlled environments - Ultra-low volume prototype work (<100 units) - Products with proprietary assembly equipment ## Assembly Track Record 820+ Device Launches Supported 12 Cleanroom Suites 25+ Years Experience Assembly Facilities ## Internal Assembly vs. LSO Partnership ### Building Your Own Cleanroom - 12-18 month facility construction timeline - $500K+ capital investment required - Regulatory validation delays - Fixed capacity regardless of demand - Hiring and training cleanroom staff - Ongoing facility maintenance costs ### LSO Assembly Services - Start production within 30-60 days - Zero capital investment required - Pre-validated cleanroom environments - Scale capacity up or down as needed - Experienced assembly technicians - Predictable per-unit pricing model ## Medical Device Assembly Questions What cleanroom classifications do you support for assembly? We operate 12 cleanrooms ranging from Class 5 to Class 8, allowing us to match the appropriate environment to your device's contamination control requirements. Can you handle both sterile and non-sterile device assembly? Yes, we have dedicated cleanroom suites for sterile device assembly as well as controlled environments for non-sterile products that still require contamination control. What documentation do you provide for regulatory submissions? We provide complete batch records, component traceability, process validation data, and statistical quality control reports that support FDA 510(k) and PMA submissions. How quickly can you scale up production volumes? We can typically increase production capacity by 300-500% within 30-60 days by adding shifts, cleanroom suites, or assembly lines as demand requires. Do you support assembly of combination products? Yes, we have experience with drug-device combinations and follow both FDA medical device regulations and pharmaceutical good manufacturing practices (cGMP). ## Get Your Assembly Process Started Skip the cleanroom construction delays. Let's discuss your device assembly requirements and timeline. [Get an Assembly Quote](https://lso-inc.com/contact/) [Schedule a Facility Tour](https://lso-inc.com/facilities-equipment/) Or call us directly: [(714) 672-1090](tel:7146721090)