Product Development Process

With over 25 years of experience in the in vitro diagnostics industry, a complete Quality Assurance process, and a laboratory experienced in many diagnostic technologies, MRN is perfectly positioned to provide complete programs for development of manual or automated diagnostic test kits.  We have brought products to market in oncology, cardiac disease, infectious disease, and transplantation medicine.   We provide complete documentation of all activities required by Design Control guidance across the Research, Development, and Clinical Validation/Commercialization phases of Product Development.   We are experienced in the design and implementation of product development staging, Design and Development plans, Design Control, and Design History files.  Comprehensive Product Development services include design and completion of Verification Studies (Analytical Validation) including Precision, Spiked Recovery and Linearity, Cross-Reactivity and Interference, Reference Ranges and other studies as required for specific types of assays.  Complete documentation is available in a form suitable for submission to FDA or other regulatory bodies.  MRN can source and test patient samples as needed to support the Product Development Process.  Together with comprehensive services in the design and execution of Clinical Validation studies and GMP manufacturing facilities under full Quality Assurance in an FDA-registered and audited environment, MRN provides a complete package of services that will achieve commercialization of new tests with the highest level of Quality Assurance possible.

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