Full-Service Medical Device CRO
QbD Clinical is a full-service CRO dedicated to medical device companies. From early feasibility and pilot studies to global clinical trials across Europe, North America, and APAC, and until PMCF studies, we accompany our sponsors in bringing safe, effective devices to patients on time and on budget.
Through a combination of in-house expertise and trusted international partnerships, our clients benefit from our team's deep expertise at every step of their clinical investigation. We help sponsors navigate EU MDR and FDA requirements, ensuring compliant, efficient, and patient‑centric clinical investigations aligned with their market‑access strategy.
Whether you are planning a European study or a global clinical investigation, we act as your single partner from strategy through execution, enabling clearer communication, smoother operations, and faster results.
Where we operate
Global coverage
With offices across Europe and a trusted network of international partners, we support medical device clinical investigations worldwide — from study start-up through close-out.
Covered directly by QbD team
Belgium, Poland, Netherlands, Luxembourg, France, UK, Germany, Spain, Italy, Austria, Switzerland
Via preferred partners & vendors
Expansion possible via vendors and partners
How can we help?
Core therapeutic areas
We support medical device manufacturers across a focused range of therapeutic areas, helping them generate robust clinical evidence for both EU MDR compliance, including MDR transition for legacy devices, and global market access.
Alongside our deep experience navigating EU regulatory pathways, we also provide strategic and operational support for FDA submissions, including pre‑submissions, 510(k), and PMA applications. We maintain full European oversight and management of clinical studies to ensure high‑quality execution and regulatory readiness across regions.
Cardiology & Vascular
Support for cardiac devices, monitoring technologies, heart failure solutions, vascular access devices, interventional technologies, and endovascular solutions.
Neurology
Expertise in neurological devices, stroke technologies, and neuro-monitoring solutions.
Orthopedic
Studies for orthopedic implants, musculoskeletal devices, and rehabilitation technologies.
Your single CRO partner from strategy to execution
We guide medical device sponsors through EU MDR and FDA requirements — ensuring compliant, efficient, and patient-centric clinical investigations aligned with your market-access strategy.
Why choose us
Why Choose QbD Clinical as Your Medical Device CRO?
A dedicated CRO built for the complexity and regulatory demands of medical device clinical research.
Deep medical device focus
We specialize exclusively in medical devices — from Class I to Class III, active implantables, and SaMD. No pharma side-projects diluting our attention.
Regulatory strength
Our in-house experts help you comply with EU MDR, ISO 14155, GCP, GDPR, and local regulations across all target markets.
Global trial execution
Experienced in running medical device trials across Europe, North America, and APAC — with trusted site networks worldwide.
Flexible, scalable model
Our modular CRO services scale with your project — from early feasibility and start-up to pivotal trials and post-market follow-up.
Embedded collaboration
We integrate seamlessly with your internal team or OEM partners to maximize efficiency and results.
Our team
Meet our experts
Conducting clinical trials for medical devices requires a unique combination of regulatory insight, clinical expertise, and a deep understanding of device-specific requirements.
Dr. Diane Fairweather
Head of Global Clinical Division
20+ years in clinical research leadership.
- 20+ years in clinical research and medical device development
- Strategic oversight of global clinical programs
- Deep expertise in EU MDR, FDA, and international regulatory frameworks
Julie Hendrickx
MD CRO Project Management Lead
20+ years clinical project delivery experience.
- International experience in Pharma and MD field
- 8+ years as Clinical Project Manager
- Project Management from study start-up to close-out
Petra De Geest
Business Unit Manager Medical Affairs
12 years experience in MD field.
- MD clinical evidence and medical writing (Class I to Class III, including MDSW and AI-driven MDSW)
- Safety Management in MD clinical investigations
- Strategic leadership & consultancy
Sarah Andries
Senior Consultant RA
12 years of experience in MD field.
- 10 years in Clinical Regulatory
- Regulatory Authority & Ethics committee submissions
- MDR & National legislations and requirements (EU)
- EU Legal Representative
Advisory Board
Meet the Advisory Board
Our Medical Advisory Board brings together experienced life sciences professionals who provide expert guidance on clinical strategy, patient safety, scientific rigor, and regulatory compliance.
Pierfrancesco Agostoni
Interventional Cardiologist
- 20+ years of experience in invasive and interventional cardiology
- Performs 300–400 complex PCIs and ~80 TAVI procedures per year
- Expert in CTO interventions, radial access, and advanced percutaneous techniques
- 310+ PubMed-indexed publications and 10+ book chapters
Gijs Klarenbeek
Physician & Clinical Development Expert
- Medical doctor with training in general surgery
- Extensive experience in clinical development and regulatory approval of medical devices
- Therapeutic expertise in cardiovascular, respiratory, oncology, diabetes, and more
Djordje Lazovic
Orthopedic Surgeon & Professor
- Professor at the European Medical School Oldenburg-Groningen
- Specialized in knee surgery, endoprosthetics, and surgical navigation
- Combines clinical expertise with academic leadership in orthopedic innovation
Proven results across therapeutic areas
From cardiology and vascular devices to neurology and orthopedics, our specialized CRO team delivers regulatory-ready clinical evidence that meets the highest standards.
Client cases
Recent client cases: real-world results across therapeutic areas
Explore some of our recent studies and projects, ranging from SaMD and heart failure to stroke and osteoarthritis.
VascularVascular | SaMD
Supported a 5-year post-market registry for coronary artery disease SaMD across 4 sites in the Middle East, Europe, and the US. Delivered full project oversight, site management, and local resource support for 394 subjects.
CardiologyCardio | Heart Failure
Managed a First-in-Human follow-up study for in-heart microcomputer technology targeting ischemic heart disease. Spanning 12 sites in Europe and the Middle East with 30 enrolled subjects, we provided regulatory submissions, monitoring, and MDR consulting.
NeurologyNeuro | Stroke
Led a pivotal interventional study across the EU and US for stroke-related aspiration catheters. Forecasted for 277 subjects, our full CRO services included submissions, biostatistics, and data management.
OrthopedicOrtho | Osteoarthritis
Oversaw a First-in-Human startup study for intra-articular hydrogel injections treating knee osteoarthritis. Conducted at up to 6 sites in Belgium, with full medical writing, biostatistics, and safety monitoring support for 99 forecasted subjects.
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.
FAQ
What you need to know
Plan your clinical pathway
From gap assessment to full CRO delivery, our clinical experts are ready to support your MedTech journey.