IVD contract manufacturing without compromising precision

We manufacture IVD cartridges, lateral flow devices, microfluidic consumables, reagent kits, and point-of-care diagnostic devices. Our capabilities span from precision cartridge assembly through reagent packaging, sterilization, and fulfillment. We're best suited for devices requiring controlled-environment assembly and validated packaging at commercial volumes. We don't handle assay development or reagent formulation — we're a manufacturing partner, not a development lab.

Fill accuracy is maintained through validated dispensing equipment with in-process monitoring and statistical process control. We verify fill volumes at defined intervals during each production run and track Cpk values to ensure the process stays within specification. If fill accuracy begins to drift, automated alerts trigger immediate investigation. This is one of the most common failure points when diagnostics companies scale — we've built our processes specifically to prevent it.

Yes. We offer temperature-controlled storage and cold chain fulfillment for reagents that require 2–8°C or frozen conditions. Shipments are monitored with temperature indicators, and our fulfillment team coordinates cold chain logistics with your distribution network. If your reagent has specific stability requirements, we build those into the packaging and shipping protocols from the start.

Design transfer is collaborative, not a handoff over a wall. We start with a DFM (design for manufacturability) review of your device and process, identify any changes needed for production scale, and develop manufacturing procedures in partnership with your R&D team. Pilot production runs validate that assay performance is maintained through the transfer. Your team stays involved through validation — we don't disappear with your design and come back with problems.

Typical timeline is 9–17 weeks depending on device complexity. This breaks down to: technical assessment (1 week), process development (2–4 weeks), IQ/OQ/PQ validation (4–8 weeks), and pilot production (2–4 weeks). If you already have validated processes from a previous manufacturer, the timeline can compress significantly. We provide a detailed project plan with milestones during the initial assessment.

Yes. For sterile devices, we offer in-house EtO sterilization validation and processing, plus coordinated gamma sterilization through qualified partners. For non-sterile consumables and kits, we have dedicated non-sterile packaging lines. Many diagnostic products include both sterile and non-sterile components in the same kit — we manage the full configuration under one quality system so you don't need to coordinate between separate sterilization and packaging vendors.

You receive complete validation packages including IQ/OQ/PQ protocols and reports, device history records, process control documentation, batch records, and traceability data. Everything is formatted for FDA 510(k), De Novo, PMA, or EU MDR technical file requirements. Our documentation has supported diagnostics submissions across multiple regulatory bodies — we know what reviewers expect and structure our deliverables accordingly.

Yes. Our IVD contract manufacturing program supports EU IVDR (Regulation 2017/746) requirements alongside FDA 510(k) and PMA pathways. Our ISO 13485 certified quality system includes the design history file, device master record, technical file, and post-market surveillance documentation that IVDR notified bodies expect. We can produce dual-market documentation packages so you submit to FDA and EU notified body using the same validated manufacturing data.