Bringing Cardiovascular Products to Market 

As the leading cause of death in the United States, heart disease continues to be a high priority for the medical device sector. This means companies developing cardiovascular devices are under increasing pressure to deliver value and incorporate the newest technologies into their products. This requires substantial expertise, but not all companies within this sector have the necessary resources to research, develop, and market their new offerings in the most successful manner. They must be able to navigate the regulatory environment, run smooth clinical trials, and ensure reimbursement from insurance providers, among other objectives. In short, it takes a knowledgeable and experienced clinical research organization (CRO) partner to ensure cardiology medical devices make it to market. 

Our Experience in Cardiovascular Technology

Helping manufacturers overcome the many challenges they face is the focus of MCRA’s cardiovascular device consultation services. With our cardiology consultants standing by their sides, our clients successfully bring new life-saving technology to those who need it the most. Our cardiovascular team focuses on all areas of cardiovascular medical technology, including but not limited to:

  • Cardiac Ablation and Pacing Technologies

  • Coronary and Peripheral Interventions

  • Cardiac Valve Repair and Replacement

  • Cardiovascular Biologics

  • Cardiac Diagnostics and Sensing Devices

  • Artificial Intelligence and Machine Learning Algorithms

  • Cardiac Electrophysiology Devices

  • Circulatory Support Devices

  • Heart Failure Devices

  • Implantable Electrophysiology Devices

  • Structural Heart Devices

  • Vascular Surgery Devices

We offer a range of services for cardiovascular medical device studies, including global regulatory expertise and support, full service clinical research organization services, reimbursement and market access, quality assurance, healthcare compliance, and cybersecurity.

Our mission is to provide best-in-class cardiovascular device consultation to help our clients achieve their product development and commercialization goals. The battery of services in the MCRA Cardiovascular portfolio enables us to partner with our clients through the various stages of the innovation process, from conception, through pre-market development and regulatory approval, to widespread market use and payer adoption. As stewards of technologies intended to treat the leading cause of death in the United States, the MCRA Cardiovascular team'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.

Contact a Cardiovascular Expert

Cardiovascular Expertise

MCRA's Cardiovascular team has decades of combined cardiovascular experience across all of our core service areas. Our cardiovascular and cardiology specialization means we are capable of taking on projects of any size and complexity.

Meet MCRA's team of talented cardiovascular industry experts.

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Michael John, MPH

Michael John, MPH

Vice President, Head of Cardiovascular Regulatory Affairs
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Fernando Aguel, M.S.

Fernando Aguel, M.S.

Vice President, Heart Failure & Circulatory Support Regulatory Affairs
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Lisa Beck, BSN, M.S.

Lisa Beck, BSN, M.S.

Senior Director, Clinical Affairs

Cardiovascular Device Services