Our Experience in In-Vitro Diagnostic Devices

Our mission is to provide best-in-class regulatory, clinical, and reimbursement services to help our clients achieve their product development and commercialization goals. We have structured our approach to navigating the regulatory and commercial landscape to align with the focus on the Total Product Life Cycle, a regulatory framework that integrates all aspects of product development and post-market surveillance. The battery of services in MCRA’s in vitro diagnostic device (IVD) portfolio therefore enables us to partner with our clients through the various stages of the innovation process, from design, through pre-market development and market approval, to reimbursement.

As stewards of technologies intended to diagnose or monitor a diverse array of health conditions, MCRA’s social responsibility is woven into the fabric of what we do and fuels our passion to bring the most advanced IVDs to market so that they can be used to improve the outcomes of those in need.

MCRA IVD has decades of combined experience and direct oversight from former FDA and Notified Body personnel from the IVD field, and are capable of taking on projects of any complexity, in diverse product areas.

For further information on our services per geography, please follow the below links:


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