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.
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
Assembly Process Design
Our engineers review your device design, create assembly work instructions, and establish quality checkpoints for optimal manufacturability.
Cleanroom Setup & Validation
We configure the appropriate cleanroom environment, validate all equipment, and establish environmental monitoring protocols.
Component Receiving & Inspection
Incoming materials are received, inspected per your specifications, and stored in controlled conditions with full traceability.
Assembly & In-Process Testing
Trained technicians assemble your devices following validated procedures with real-time quality monitoring at each step.
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
3
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
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.
Yes, we have dedicated cleanroom suites for sterile device assembly as well as controlled environments for non-sterile products that still require contamination control.
We provide complete batch records, component traceability, process validation data, and statistical quality control reports that support FDA 510(k) and PMA submissions.
We can typically increase production capacity by 300-500% within 30-60 days by adding shifts, cleanroom suites, or assembly lines as demand requires.
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.
Or call us directly: (714) 672-1090