CARDIOVASCULAR THERAPEUTIC EXPERTISE

Cardiovascular medical device consulting for complex market pathways

Navigate regulatory, clinical, and commercialization challenges with specialized cardiovascular expertise from IQVIA MedTech. IQVIA MedTech helps cardiovascular device companies navigate regulatory requirements, generate evidence, and build market access strategies to accelerate success.
Connect with a Cardiovascular Expert
Sub Brands MedTech Homepage Therapeutic Areas Cardiovascular Medical Device Consulting

From structural heart therapies and electrophysiology devices to AI-enabled diagnostics, success depends on more than innovation.

Breakthrough cardiovascular technologies demand more than technical innovation. Success requires generating robust clinical evidence, navigating evolving regulatory requirements, and demonstrating value across the healthcare ecosystem.

IQVIA MedTech combines specialized cardiovascular clinical, regulatory, market access, and commercialization expertise to help innovators navigate complexity and accelerate market success.

  • Cardiovascular Device CRO
    Clinical trials, registries, evidence generation, human factors studies, EMC testing support, and biostatistical expertise for cardiovascular technologies.
  • Regulatory Services
     Regulatory strategy, submissions, global market authorization support, and expertise in biocompatibility and cybersecurity requirements.
  • Reimbursement & Market Access
     HEOR, coverage, coding, payment strategy, and evidence development to support market access and reimbursement success
  • Commercialization
     Market assessment, launch planning, competitive intelligence, and commercialization strategies to support growth and adoption
  • Quality & Compliance
     QMS, risk management, remediation, and post-market surveillance expertise

Specialized expertise across the cardiovascular device landscape

We support cardiovascular innovators across a broad range of devices, from structural heart and electrophysiology technologies to diagnostics, monitoring, and vascular interventions.

They include, but are not limited to:

Heart surgeon exam patient heart on a computer Heart health concept

Beyond Traditional Devices: Digital Health, Biologics & Combination Products

As cardiovascular technologies become increasingly connected, data-driven, and multidisciplinary, companies face new challenges that extend beyond traditional device development.

  • Digital Health & Software as a Medical Device (SaMD): AI-enabled diagnostics, cardiac imaging algorithms, arrhythmia prediction platforms, digital therapeutics, connected care solutions, and remote monitoring technologies.
  • Biologics & Combination Products: Tissue-engineered therapies, regenerative medicine approaches, cell therapies, biologic-device combinations, and drug-device combination products designed to address complex cardiovascular conditions

Proven outcomes: Cardiovascular trials

190+

CARDIOVASCULAR DEVICE TRIALS CONDUCTED

63+

COUNTRIES

100%

PMA APPROVAL RATE

Cardiovascular Success Story: Exceeding Enrollment Goals Ahead of Schedule

A large manufacturer of cardiovascular grafts and patches needed to scale its post-market trial to meet new EU MDR requirements and inform future product development amid the COVID-19 global pandemic.
To ensure high-quality data and efficient execution, the manufacturer needed a global CRO partner with a strong global site network and an experienced bilingual clinical operations team.
Challenge

While initial enrollment targets were achievable, the study required activating sites across multiple European countries and managing five large patient cohorts through follow-up.
When the pandemic disrupted sites in the UK and Italy, maintaining study timelines required rapid adaptation, replacement site activation, and operational agility across all participating regions.
Solution

With a commitment to flexibility, IQVIA MedTech leveraged its global network and cardiovascular post-market clinical experience to exceed patient enrollment goals by 6 months.
Selecting alternate test sites and deploying experienced CRAs fluent in local languages, we oversaw testing while maintaining consistency across all participating countries as we collected retrospective and prospective data to evaluate long-term safety and performance.
Results

  • 1,665 patients enrolled — including 1,335 in Europe and 300 in North America
  • 5 CRAs in Europe — conducted 60 visits (and counting), monitored 1,600 consent forms, and reviewed 15 case report forms per patient.
Enrollment remains ongoing for two study arms, with follow-up visits, ongoing source data review (SDV), and data management continuing for 10 years after implantation.
MCRA IS NOW PART OF IQVIA MEDTECH
Cardiovascular Expertise That Drives Life-Changing Innovation
From structural heart and electrophysiology to vascular interventions, cardiac diagnostics, and AI-enabled technologies, MCRA helps cardiovascular innovators navigate every stage of the product lifecycle. With deep expertise in regulatory strategy, clinical research, reimbursement, quality, and commercialization, we help bring breakthrough cardiovascular technologies to market with confidence.
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Frequently asked questions about cardiovascular medical device consulting

Cardiovascular trials are often high-risk, expensive, and heavily scrutinized by regulatory agencies. Conducting cardiovascular device clinical research without built-in regulatory foresight can lead to unapproved protocol amendments or missed endpoints. Our integrated methodology ensures your clinical trial design explicitly captures the safety, efficacy, and HEOR data needed for regulatory approvals and payer coverage.
We have a dedicated digital health team that specializes in cardiovascular AI, machine learning algorithms, and remote monitoring tools. We help developers classify their software, navigate FDA pre-submissions, manage cybersecurity expectations, and prove clinical validity.
Yes. Our global cardiovascular device regulatory consulting network routinely conducts gap analyses, updates clinical evaluation reports (CERs), and restructures technical documentation to maintain compliance and avoid market disruption under EU MDR rules.
Ready to advance your next cardiovascular breakthrough?
Partner with experts across clinical development, regulatory strategy, and commercialization to accelerate your path to market.
TALK TO OUR CARDIOVASCULAR EXPERTS

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