Scroll Back to Top

Cardiovascular Medical Device and Diagnostics Development

Connect with us

Broad Cardiovascular Experience

Specialized medical device and diagnostics experience supporting cardiovascular programs from early feasibility and first-in-human studies through pivotal trials and post-market activities

Global Development Capabilities

Global development experience and regulatory knowledge supporting multinational studies, including FDA, EU MDR/IVDR and UK requirements

Operational Delivery for Complex Studies

Coordinated clinical operations, medical monitoring, biostatistics, data management and quality focused processes supporting consistent execution of complex cardiovascular studies

Advancing Cardiovascular Device and Diagnostics Programs Across the Development Lifecycle

Fortrea supports sponsors in advancing cardiovascular medical devices, in vitro diagnostics (IVDs) and digital health technologies throughout development, from early feasibility studies to post-market evidence generation, helping bring innovative solutions to patients worldwide.

Our teams have experience supporting a broad range of vascular technologies, including peripheral and coronary interventions, drug-coated technologies, stents, thrombectomy devices, embolization products, vascular access solutions, and structural heart interventions.

Advancing Cardiovascular Device and Diagnostics Programs Across the Development Lifecycle

Over a 5-year period within cardiovascular specifically:

This breadth supports delivery across diverse geographies and patient populations.

85 trials
979 Sites
38,187 patients

Why Fortrea for Cardiovascular Device and Diagnostics Development?

  • Dedicated Medical Device & Diagnostics Experience: Specialized teams experienced in cardiovascular devices, diagnostics, software-enabled technologies and combination products.
  • End-to-End Lifecycle Support: From first-in-human and early feasibility studies through clinical and analytical performance studies, pivotal PMA/CE-marking studies, post-approval commitments, registries, post-market clinical follow-up (PMCF), post-market
  • Global Regulatory Experience: Support for FDA, EU MDR/IVDR, UK and global regulatory frameworks, helping sponsors effectively navigate evolving requirements and maintain compliance throughout the product lifecycle.
  • Complex Study Execution: Experience managing multinational cardiovascular studies involving implantable devices, structural heart technologies, vascular interventions, electrophysiology systems, and cardiovascular diagnostics.
  • Integrated Cross-Functional Delivery: Clinical operations, medical monitoring, biostatistics, data management, safety, regulatory affairs, quality, and project leadership working as a unified team.
  • Quality-Focused Approach: Proven processes supporting inspection readiness, data integrity, patient safety and regulatory compliance throughout development.
  • Explore How Fortrea Can Support Your Cardiovascular Development Program 

    Beyond traditional clinical trial execution, Fortrea's Medical Device & Diagnostics team supports sponsors with development strategy, regulatory pathway planning, risk-based study design, evidence generation, clinical evaluation support, and post-market evidence programs. Our experience spans Class II and Class III cardiovascular technologies, implantable devices, diagnostics, connected health solutions, and software-enabled medical technologies, helping sponsors efficiently progress from concept to commercialization.

    Supporting a Range of Cardiovascular Technologies

    Fortrea supports development programs across multiple cardiovascular therapy areas, including:

    • Structural Heart

      Fortrea supports structural heart programs that use transcatheter and surgical approaches to treat valve disease and other structural conditions. Our experience covers aortic, mitral and tricuspid valve repair and replacement, surgical heart valves, annuloplasty systems and left atrial appendage closure devices. We support the full lifecycle, from early feasibility and first-in-human studies through pivotal, post-approval and registry studies. That includes selecting experienced implanting centres and coordinating imaging and long-term follow-up.

    • Coronary and Peripheral Vascular Disease

      Our teams support interventions that restore blood flow and treat vascular disorders. Indications include coronary artery disease, acute coronary syndrome, peripheral artery disease, and abdominal and thoracic aortic aneurysms.  Device types include coronary and peripheral drug-eluting stents, drug-coated balloons, endovascular and thoracic aortic stent grafts, venous stents and thrombectomy systems. We also support studies that need long-term follow-up across multiple countries.

    • Cardiac Rhythm Management

      Fortrea supports the clinical development of pacing, defibrillation, electrophysiology and rhythm-monitoring technologies. Our experience includes permanent and leadless pacemakers, implantable cardioverter-defibrillators (ICDs), cardiac resynchronisation therapy (CRT) devices, ablation catheters and implantable loop recorders. Atrial fibrillation is one of the top indications in our cardiovascular device portfolio.

    • Cardiovascular Diagnostics

      We support evidence generation for cardiovascular diagnostic devices, IVDs and biomarker-based technologies, as well as imaging solutions. Our support spans clinical performance studies and regulatory pathways under FDA, EU MDR/IVDR and UK requirements. Integrated data management, biostatistics and quality oversight help produce robust evidence for regulatory, reimbursement and commercial decisions.

    • Digital Cardiovascular Health

      Fortrea has experience with connected technologies, wearable devices, software-enabled medical technologies and remote patient monitoring, including heart failure monitoring technologies. We help sponsors design studies that capture continuous, real-world data and handle the data integrity and usability needs specific to digital health.

    Our Medical Device & Diagnostics team has successfully supported sponsors developing:

    • Transcatheter aortic, mitral and tricuspid valve technologies 
    • Coronary, peripheral vascular and venous intervention devices 
    • Leadless pacemakers, ICDs, CRT systems and electrophysiology platforms 
    • Heart failure monitoring and mechanical circulatory support technologies 
    • Cardiovascular diagnostic and biomarker-based testing solutions 
    • Connected health, wearable monitoring and AI-enabled cardiovascular technologies 
    • Post-market registries and long-term follow-up programs supporting global regulatory and commercial objectives

    From first-in-human investigations to global pivotal studies and post-market evidence programs, Fortrea provides integrated clinical, regulatory, operational and scientific experience to help sponsors advance innovative cardiovascular technologies from concept to commercialization

    Frequently Asked Questions (FAQs)

    Ready to advance your cardiovascular device or diagnostic program?

    Connect with our team to discuss your development goals and explore solutions that support your clinical, regulatory, and commercial objectives.

    Choose how you like to connect.

    We've been driving innovation with our tailored clinical solutions for 30+ years. Let's connect.

    Write to us
    Book a Meeting

    Prefer to send an inquiry?

    Tell us about your needs and our team will follow up shortly.

    Service Interest(s) *
    (Word, PDF, PPT, Excel, Image)
    One file only.
    60 MB limit.
    Allowed types: gif jpg jpeg png bmp txt rtf html pdf doc docx ppt pptx xls xlsx xml.
    Name

    I agree to be contacted about products and services and receive other communications from Fortrea Inc. Please review Fortrea's Privacy Policy for further information. By submitting below, you consent to allow Fortrea Inc to store and process the personal information submitted above to provide you the content requested.

    By clicking submit below, you consent to allow Fortrea Inc to store and process the personal information submitted above to provide you the content requested.

    Schedule a time with a Fortrea Specialist

    Connect with our team to discuss your needs and explore the right solutions for your clinical development goals — quick, clear, and hassle‑free.