Our Experience in Cardiovascular Medical Devices

Our mission is to provide our best-in-class services, including regulatory, clinical, and reimbursement, to help our clients achieve their product development and commercialization goals for cardiology medical devices. 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 the MCRA Cardiovascular 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 Cardiovascular 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 multiple former FDA personnel in cardiovascular devices. Our cardiology specialization means we are capable of taking on projects of any complexity, including (but not limited to) those within the following product areas:

  • Cardiac Ablation and Pacing technologies
  • Coronary and Peripheral interventions
  • Cardiac valve repair and replacement
  • Cardiovascular biologics
  • Cardiac Diagnostics Devices
  • Cardiac Electrophysiology Devices
  • Circulatory Support Devices
  • Interventional Cardiology Devices
  • Implantable Electrophysiology Devices
  • Structural Heart Devices
  • Vascular Surgery Devices


Contact a Cardiovascular Expert