End-to-end manufacturing for diagnostic devices, reagents, and consumables with FDA-registered, ISO 13485-certified cleanroom services.
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.
Optimizing your diagnostic device for scalability, cost-efficiency, and regulatory compliance begins with design for manufacturing (DFM). LSO provides:
Our specialized reagent formulation services ensure stability, accuracy, and consistency in diagnostic testing. LSO offers:
Accurate dispensing and packaging of liquid and lyophilized reagents is critical to diagnostic test performance. Our capabilities include:
LSO provides turnkey assembly services for disposable diagnostic cartridges, cassettes, and consumables. Our expertise includes:
Ensure your diagnostic test kits are market-ready with our custom packaging and kitting services. LSO specializes in:
Life Science Outsourcing is an FDA registered and ISO 13485 certified full service Medical Device Contract Manufacturer.
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