Diagnostics Device Manufacturing & Assembly
End-to-end manufacturing for diagnostic devices, reagents, and consumables. DFM, cartridge assembly, reagent packaging, and sterilization under one FDA-registered, ISO 13485 quality system.
End-to-end manufacturing for diagnostic devices, reagents, and consumables with FDA-registered, ISO 13485-certified cleanroom services.
End-to-End Solutions for Diagnostic Device Development
Bringing diagnostic devices and consumables to market requires precision, regulatory expertise, and scalable manufacturing solutions. At Life Science Outsourcing (LSO), we specialize in designing, assembling, and packaging in-vitro diagnostics (IVD) devices, reagent formulations, and consumable components to help diagnostics companies accelerate commercialization while ensuring compliance with FDA and ISO 13485 standards.
From early-stage design for manufacturing (DFM) to high-volume production and sterile packaging, our comprehensive, in-house solutions support rapid product development and regulatory approval.
Design for Manufacturing (DFM) for Diagnostic Devices
Optimizing your diagnostic device for scalability, cost-efficiency, and regulatory compliance begins with design for manufacturing (DFM). LSO provides:
- Material selection and component integration support
- DFM analysis to streamline production and reduce costs
- Risk mitigation strategies for regulatory approval
Reagent Formulation & Handling
Our specialized reagent formulation services ensure stability, accuracy, and consistency in diagnostic testing. LSO offers:
- Custom reagent formulation for IVD applications
- Controlled environment mixing, filling, and storage
- Compliance with FDA and ISO 13485 quality standards
Precision Reagent Packaging
Accurate dispensing and packaging of liquid and lyophilized reagents is critical to diagnostic test performance. Our capabilities include:
- Precision liquid filling and reagent aliquoting
- Custom vial and bottle packaging
- Sterile and non-sterile packaging options
Cartridge & Consumable Assembly
LSO provides turnkey assembly services for disposable diagnostic cartridges, cassettes, and consumables. Our expertise includes:
- Automated and manual assembly of microfluidic and diagnostic test cartridges
- Sealing and integration of membranes, filters, and reagent chambers
- Quality inspection and performance testing for regulatory compliance
Diagnostics Packaging & Kitting
Ensure your diagnostic test kits are market-ready with our custom packaging and kitting services. LSO specializes in:
- Sterile barrier packaging for single-use diagnostic tests
- Custom diagnostic test kitting, including reagents, swabs, and sample collection tools
- Full package validation and compliance with ISO 11607 standards
Why LSO?
LSO's diagnostics capabilities were purpose-built through the January 2023 acquisition of J-Pac Medical — bringing precision reagent packaging, microfluidic cartridge assembly, and diagnostics-specific DFM expertise under LSO's FDA-registered, ISO 13485 certified quality system.
For diagnostics manufacturers, this means a single partner for the complete manufacturing workflow: DFM review, reagent handling, cartridge assembly, validated packaging, sterilization, labeling, and fulfillment. No inter-vendor handoffs. No quality system gaps. One partner from pilot to millions of units.
With 12 cleanrooms (Class 5–8), controlled-environment manufacturing across three facilities, and 25+ years of regulated manufacturing experience, LSO has the infrastructure and expertise to scale your diagnostics consumables without compromising the precision that your assay demands.
- FDA-Registered, ISO 13485-Certified – Ensuring compliance with the highest industry standards
- End-to-End Manufacturing & Assembly – From prototyping to full-scale production
- Bicoastal & Nearshore Operations – Facilities in California, New Hampshire, and Costa Rica for cost-effective, scalable solutions
- Quick-Turn Services – Faster sterilization, validation, and lot release to accelerate market entry
- Proven Expertise in Medical Devices – Supporting orthopedics, neuromodulation, cardiovascular devices, and more
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
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