OEM MANUFACTURING
Reliable, scalable, and compliant OEM manufacturing for in vitro diagnostic devices. From product feasibility to final market release, we cover all processes including design documents, manufacturing lot validations, in-process QC materials, and final release to meet your OEM product requirements. Choose MRN Diagnostics for trusted expertise, proven quality, and unmatched flexibility.
SCALABLE OEM SOLUTIONS
Explore our full range of OEM manufacturing solutions, including custom controls, diagnostic panels, and large-scale bioprocessing designed to meet your assay development and manufacturing needs.
Liquid and swab-based quality controls and calibrators for serology, antigen, and molecular testing. Covers testing formats from CLIA-Waived point-of-care to large-scale screening platforms.
Custom in-process quality control panel design and development.
GMP-compliant plasma and serum processing (defibrination, diafiltration, lipid stripping, sterile filtration, viral inactivation, and stabilization).
Large-scale bioprocessing for volumes up to 500L.
CUSTOM OEM MANUFACTURING
At MRN Diagnostics, we provide fast, flexible, and fully customized OEM manufacturing solutions for diagnostic developers. We tailor every control and QC panel to meet your exact product specifications.
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Our manufacturing process are cGMP and ISO 13485:2016 compliant, which provides the regulatory support and documentation needed for audits, manufacturing operations, and submissions for
regulatory approval.
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We offer end-to-end support, working closely with your team from design to delivery to ensure your components align with your assay and workflow. When you choose MRN Diagnostics, you gain a responsive, expert partner committed to helping you bring your diagnostics to the market.
