Your CRO for Cardiology Medical Devices
Specialized support for clinical research in cardiology
As a European CRO dedicated to medical devices, we offer deep expertise in Cardiology Medical Device clinical research. From heart failure devices and stents to structural heart innovations, we support your journey from strategy to post-market follow-up.
At QbD Clinical, we know your priority is delivering innovative cardiology medical devices to patients — safely and efficiently. That's why we don't just run clinical trials; we collaborate with you to drive results.
How can we help?
Our CRO Services for Cardiology Medical Devices
From strategy to submission, from study design to post-market monitoring — we've got you covered.
Clinical & Operational Support
- Site selection, qualification, training & management
- On-site & remote monitoring (incl. risk-based)
- Trial logistics & coordination
- Safety management and reporting
Regulatory Strategy
- Country-specific regulatory intelligence
- Submission packages (ECs & CAs)
- Medical device safety reporting
Medical & Scientific Writing
- Study protocols & clinical investigation plans
- Clinical study reports (CSR/CIR)
- Investigator brochures (IB)
- PMCF plans and reports
Data Management & Biostatistics
- Electronic data capture (EDC, ePRO)
- Data cleaning, coding & analysis
- Biostatistics & SAS programming
- Reporting and analytics
Why choose us
Why Choose QbD Clinical for Cardiology Trials?
The right CRO for high-risk, high-reward innovation.
Cardiology expertise
We support Class IIb and III devices with deep therapeutic knowledge across the cardiovascular field.
Regulatory strength
Our in-house experts help you comply with EU MDR, ISO 14155, GCP, GDPR, and local regulations.
Global trial execution
Experienced in running cardiology trials across Europe, North America, and APAC — with trusted site networks worldwide.
Flexible, scalable model
Our modular CRO services scale with your project — from start-up to pivotal trial to PMCF.
Embedded collaboration
We integrate seamlessly with your internal team or OEM partners to maximize efficiency and results.
Case studies
Featured CRO Case Studies
We bring hands-on expertise to complex cardiovascular studies — from first-in-human trials to global post-market programs.
Heart FailureHeart Failure Study – First-In-Human Device
- Supported a first-in-human clinical study for an in-heart microcomputer treating ischemic heart disease.
- Managed 12 sites across Europe and the Middle East, involving 45 enrolled subjects.
- Delivered end-to-end clinical support: regulatory submissions, project and site management, monitoring, and medical writing.
- Provided MDR compliance consulting throughout the trial lifecycle.
Structural Heart Study – Pivotal Trial in EU
- Oversaw a pivotal study for an ultrasound therapy device targeting aortic valve disease.
- Managed 11 sites across Europe, enrolling 60 subjects with one-year follow-up.
- Delivered full-service CRO support, including regulatory submissions, biostatistics, safety and data management, and core lab coordination.
- Facilitated CEC and DSMB oversight to ensure robust clinical governance.
Post-Market Study – Arrhythmia Device
- Supporting a large-scale post-market study for a device treating atrial fibrillation and left atrial appendage exclusion.
- Coordinating up to 24 sites across Europe and Asia-Pacific, with a global forecast of 6,500+ subjects.
- Stepped in as a rescue CRO, taking over monitoring, site management, and regulatory submissions mid-study.
- Ensuring smooth OUS oversight and operational continuity across regions.
VascularVascular SaMD – Post-Market Registry
- Managed a five-year post-market registry for a coronary artery disease SaMD.
- Operated across 4 sites in the Middle East, Europe, and the US, enrolling 394 subjects.
- Provided local resource coordination, site management, and ongoing project oversight.
- Supported dynamic coronary roadmap monitoring and long-term safety tracking.
Meet the team
Connect with Our Cardiology CRO Experts
Julie Hendrickx
MD CRO Project Management Lead
Petra De Geest
Medical Affairs Manager
Sarah Andries
Head of Clinical Operations
"QbD Clinical brought deep cardiology expertise, proactive communication, and true flexibility to our pivotal trial. Their team felt like an extension of ours — fast, knowledgeable, and fully aligned with our timelines and regulatory goals."
— VP Clinical Affairs, European MedTech company (structural heart)
Why QbD Group
Your trusted partner
We support MedTech companies with regulatory expertise across MDR, FDA, IVDR, ISO 14155, ICH-GCP, and our close collaboration with Notified Bodies, enabling trust, transparency, and faster outcomes.
MedTech expertise
focused exclusively on medical devices, IVD and companion diagnostics.
Trusted partner
proven track record with innovators and established MedTech companies alike.
Quality at every step
rigorous processes ensure clinical evidence that meets regulatory expectations.
Right-sized solutions on budget
we scale our services to match your project needs and timeline.
Plan your clinical pathway
From gap assessment to full CRO delivery, our clinical experts are ready to support your MedTech journey.