Product Development Services

MRN offers complete Laboratory Services under a comprehensive Quality System for development of new diagnostic tests.  We are expert in the development of Laboratory Developed Tests as well as providing FDA-ready data for 510(k), PMA or BLA submissions.  We have complete documentation services available including all phases of research and development. We conduct Design and Development and Design Control planning with thorough documentation.  We have long experience in the design of Verification studies (sometimes referred to as Analytical Validation) such as Imprecision, Spiked Recovery and Linearity, Cross Reactivity and Interfering Substances, Reference Ranges, and other Verification studies as required for specific assays.  We provide a complete Design and Development Plan, execute all studies and provide thorough documentation submittable to regulatory authorities in the US, Europe and other countries.  When combined with our expertise in Clinical Validation trials and GMP test kit manufacturing, MRN provides a comprehensive line of diagnostic test commercialization skills compatible with the most aggressive timelines in the industry.

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