--- title: "Full-Service Medical Device CRO | QbD Group" description: "A full-service medical device CRO covering clinical strategy, study operations, monitoring, data management and regulatory reporting under MDR and IVDR." url: https://qbdgroup.com/en/services/full-service-medical-device-cro type: "Page" language: en publisher: "QbD Group" citation: "QbD Group, \"Full-Service Medical Device CRO | QbD Group\", https://qbdgroup.com/en/services/full-service-medical-device-cro" --- # 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, 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 & VascularSupport for cardiac devices, monitoring technologies, heart failure solutions, vascular access devices, interventional technologies, and endovascular solutions.](https://qbdgroup.com/en/industries/medical-devices/md-cro-cardiology) ### Neurology Expertise in neurological devices, stroke technologies, and neuro-monitoring solutions. [OrthopedicStudies for orthopedic implants, musculoskeletal devices, and rehabilitation technologies.](https://qbdgroup.com/en/industries/medical-devices/md-cro-orthopaedic-spine) ## 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](https://qbdgroup.com/en/author/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](https://qbdgroup.com/en/author/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](https://qbdgroup.com/en/author/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](https://qbdgroup.com/en/author/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](https://qbdgroup.com/en/author/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](https://qbdgroup.com/en/author/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](https://qbdgroup.com/en/author/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. Vascular ### Vascular | 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. Cardiology ### Cardio | 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. Neurology ### Neuro | 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. Orthopedic ### Ortho | 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. Contact us --- Source: https://qbdgroup.com/en/services/full-service-medical-device-cro — © QbD Group. Quote freely with attribution and a link back.