Your CRO for Cardiology Medical Devices

Specialized support for clinical research in cardiology

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.

As a European CRO dedicated exclusively to medical devices, we offer deep expertise in Cardiology Medical Device clinical research. From heart failure devices and stents to structural heart innovations and cardiovascular diagnostics, we support your journey from strategy to post-market follow-up.

Need full-service trial execution or focused regulatory support? We help you navigate complexity, accelerate timelines, and ensure MDR and ISO 14155 compliance — so you can move your cardiology innovations forward with confidence.

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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

Your Cardiology-Focused CRO for Medical Devices QbD Group (1)

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 Original Equipment Manufacturer (OEM) partners to maximize efficiency and results.

Let’s talk about your trial

Featured CRO Case Studies

We bring hands-on expertise to complex cardiovascular studies — from first-in-human trials to global post-market programs. Our team has supported a wide range of medical device studies in cardiology, including heart failure, arrhythmia, vascular, and structural heart projects. With deep therapeutic expertise, global site networks, and flexible CRO services, we help medtech innovators deliver safe, effective technologies to patients faster and with full regulatory confidence.

Your Cardiology-Focused CRO for Medical Devices QbD Group (2)

Heart 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.

Need support with your heart failure trial? Get in touch!

Your Cardiology-Focused CRO for Medical Devices QbD Group (3)

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.

Launching a heart study? Contact our experts today!

Your Cardiology-Focused CRO for Medical Devices QbD Group (4)

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.

Need help managing a large post-market study? Let’s talk.

Your Cardiology-Focused CRO for Medical Devices QbD Group (5)

Vascular SaMD – Post-Market Registry

Managed a five-year post-market registry for a coronary artery disease SaMD (Software as a Medical Device).
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.

Looking for vascular SaMD trial support? Contact us.

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.

Name client

VP Clinical Affairs, European MedTech company (structural heart)

Connect with Our Team of CRO Experts

Josie Rose

Sr. Pharmaceutical Strategist

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Josie Rose

Sr. Pharmaceutical Strategist

Schedule a meeting

Josie Rose

Sr. Pharmaceutical Strategist

Schedule a meeting

Josie Rose

Sr. Pharmaceutical Strategist

Schedule a meeting

Resources

Case study

Fast-Tracked Site Qualification for Clinical Trial Submission

QbD Group helped a biotech company complete 5 site qualification visits in just 3 weeks enabling a timely and compliant clinical trial submission.

Webinar

Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation

Discover how to integrate clinical needs into medical device software design to meet MDR requirements. Watch our webinar on demand.

Whitepaper

Clinical Evaluation for Medical Devices under MDR

This whitepaper will guide you through crucial regulatory documents pertaining to the clinical evaluation process of your medical device. Download now!

Whitepaper

IVDR extension: what does this mean for you?

In this whitepaper, you will learn the impact of the IVDR transition extension and receive tips and strategies to navigate these regulatory changes.

Whitepaper

State-of-the-art literature review: kick off the Clinical Evaluation of your Medical Device

This whitepaper will walk you through the steps of conducting solid systematic SOTA literature searches for your clinical evaluation. Download now.

Whitepaper

Clinical investigations under MDR: key insights and practical experiences

This whitepaper covers clinical investigation authorization under MDR, the EU Legal Representative's role, and the MDR's impact on study conduct and post-market surveillance.

Whitepaper

The pathway from idea to patient under MDR

This guide explains the pathway and steps needed to test your device in human subjects, aiming to get your product to market. Download now.

Case study

CE Mark Renewal for bioXtra Products: A Success Story

Discover how Lifestream Pharma successfully renewed the CE mark for their BioXtra Dry Mouth products under the EU MDR. Learn about the challenges faced, the approach taken for compliance, and the results achieved.

Webinar

Getting Started: Overcoming Initial Obstacles in Medical Device Software Development

Watch our webinar on demand and learn about regulatory obstacles, MDR, AI Act, and best practices for medical device software development and market entry.

Webinar

Mastering Clinical Performance Studies under IVDR

In the evolving regulatory landscape of IVDs, demonstrating clinical performance is more crucial and challenging than ever. Discover more in this webinar on demand.

Whitepaper

Clinical evidence for In Vitro Diagnostics under IVDR

In this whitepaper, we will guide you through the documents required for the demonstration of clinical evidence under the IVDR. Download now.

Case study

Ensuring a smooth MDR transition for Oystershell's medical devices

The landscape of medical device regulations is constantly evolving, making it a challenge for companies to keep up. Our collaboration with Oystershell, which began in July 2023, highlights our expertise in transforming complex challenges into success stories, all with a touch of QbD Clinical magic.

Case study

Successful clinical evaluation supports rapid CE marking of Minze Health's Uroflowmeter

QbD Clinical assisted Minze Health, a urology-focused medical devices company, in obtaining CE marking under MDR through clinical evaluation.

Discover all

Your CRO for Cardiology Medical Devices

Our CRO Services for Cardiology Medical Devices

Clinical & Operational Support

Regulatory Strategy

Medical & Scientific Writing

Data Management & Biostatistics

Why Choose QbD Clinical for Cardiology Trials?

Featured CRO Case Studies

Heart Failure Study – First-In-Human Device

Structural Heart Study – Pivotal Trial in EU

Post-Market Study – Arrhythmia Device

Vascular SaMD – Post-Market Registry

Name client

Connect with Our Team of CRO Experts

Josie Rose

Josie Rose

Josie Rose

Josie Rose

Let’s Talk About Your Trial

Resources

Fast-Tracked Site Qualification for Clinical Trial Submission

Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation

Clinical Evaluation for Medical Devices under MDR

IVDR extension: what does this mean for you?

State-of-the-art literature review: kick off the Clinical Evaluation of your Medical Device

Clinical investigations under MDR: key insights and practical experiences

The pathway from idea to patient under MDR

CE Mark Renewal for bioXtra Products: A Success Story

Getting Started: Overcoming Initial Obstacles in Medical Device Software Development

Mastering Clinical Performance Studies under IVDR

Clinical evidence for In Vitro Diagnostics under IVDR

Ensuring a smooth MDR transition for Oystershell's medical devices

Successful clinical evaluation supports rapid CE marking of Minze Health's Uroflowmeter