Our Experience in Cardiovascular 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 FDA's focus on the Total Product Life Cycle, a regulatory framework that integrates all aspects of product development. The battery of services in MCRA Cardio's portfolio therefore enables us to partner with our clients through the various stages of the innovation process, from conception, through pre-market development and FDA approval, to widespread market use and payor reimbursement. As stewards of technologies intended to treat the leading cause of death in the United States, MCRA Cardio's social responsibility is woven into the fabric of what we do, and fuels our passion to bring the most advanced medical therapies to those in need.

MCRA Cardio has decades of combined cardiovascular experience and direct oversight from a former FDA Branch Chief in cardiovascular devices, and is capable of taking on projects of any complexity, including (but not limited to) those within the following product areas:

•    Cardiac Diagnostics Devices

•    Cardiac Electrophysiology Devices

•    Circulatory Support Devices

•    Interventional Cardiology Devices

•    Implantable Electrophysiology Devices

•    Structural Heart Devices

•    Vascular Surgery Devices