MCRA’s Cardiovascular team is at the forefront of one of the most robust and innovative therapeutic areas in MedTech.
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.
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.
Cardiovascular Device Services
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Cardiovascular Clinical Research Organization (CRO)
We bring proven expertise, first-class facilities and dedicated staff to support our clients’ devices on their journey to market. Our clients count on us to ensure their cardiovascular medical equipment is properly researched and meets all appropriate standards.
Learn more about our cardiovascular CRO services here. -
Cardiovascular US Regulatory
Our US regulatory experts have the knowledge and experience needed to guide cardiovascular devices through the complex FDA regulatory process. With our expertise working by their sides, our clients experience smooth and worry-free cardiac medical device development.
Learn more about our US regulatory services here. -
Cardiovascular Global Regulatory
When bringing devices to international markets, strong regulatory and scientific leadership are required to see them successfully through the process. No matter where they want to go, we ensure the companies we work with are able to capitalize on every available opportunity.
Learn more about our global regulatory capabilities here. -
Cardiovascular Reimbursement, Health Economics and Market Access
With the help of our more than 50 years of experience, we provide comprehensive reimbursement, health economics, and public policy services. The unique knowledge base we bring to bear for our clients makes it possible for them to enter the cardiovascular medical devices market knowing it will be economically feasible for them.
Learn more about our reimbursement services here. -
Cardiovascular Quality Assurance
We ensure that all the proper procedures for document control, R&D, risk management, software development, supplier evaluation, control of cardiology equipment, and more are in place to serve our clients. We know how important it is that cardiovascular medical devices work as they should, and our experts do everything possible to ensure that they will.
Learn more about our quality assurance services here. -
Cardiovascular Healthcare Compliance
The complexity of today’s legal and regulatory environment requires the extensive expertise in compliance that our experts can provide. With our help, clients can bring their cardiology devices through the approval process with success and minimal difficulty.
Learn more about our cardiovascular compliance assistance here. -
Cardiovascular Cybersecurity
Securing and protecting advanced medical devices from cybercrime and data breaches is of the utmost importance today, and we have the solutions to provide the highest levels of protection. We have the knowledge required to find and resolve any weak spots that may exist within our clients’ cybersecurity.