Your CRO for Orthopedic Medical Devices

Advancing musculoskeletal device trials with precision and purpose

Orthopedic medical devices are evolving rapidly — from smart implants and bioresorbable materials to minimally invasive surgical systems. At QbD Clinical, we specialize in helping medtech companies bring these innovations to life through expertly managed clinical trials.

Unlike generalist CROs, we focus exclusively on medical devices, with a dedicated track record in orthopedic clinical research. Whether you're developing a novel spinal implant, a regenerative therapy for cartilage repair, or a next-gen joint prosthesis, we provide the strategic and operational support to move your study forward — compliantly and confidently.

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Clinical Operations

Investigator and site selection with orthopedic specialization
On-site and remote monitoring (risk-based and adaptive)
Trial logistics and vendor coordination
Safety oversight and adverse event reporting

Regulatory & Compliance

MDR and ISO 14155-aligned regulatory strategy
Ethics and Competent Authority submissions
Vigilance and device safety reporting

Medical & Scientific Writing

Protocols, IBs, and clinical investigation plans

Clinical evaluation and study reports

PMCF documentation and registry support

Data & Biostatistics

EDC setup and ePRO integration

Statistical planning and analysis

Data cleaning, coding, and reporting

Your CRO for Orthopedic Medical Devices (1)

Why QbD Clinical for Orthopedic Trials?

We understand the complexity of orthopedic trials — and how to simplify it.

Therapeutic Focus
We’ve supported trials in osteoarthritis, spinal disorders, trauma, and sports medicine — including Class IIb and III implants and combination products.
Real-World Experience
From First-in-Human studies to long-term follow-up, we’ve managed orthopedic trials across Europe, North America, and Asia-Pacific.
Integrated Expertise
Our team includes orthopedic surgeons, regulatory strategists, data scientists, and clinical project managers — all under one roof.
Scalable Support
Whether you need full-service trial execution or targeted support, our modular model adapts to your needs and timelines.
Collaborative Approach
We work as an extension of your team, aligning with your internal processes and external partners to ensure seamless execution.

Let’s talk about your trial

Orthopedic Case Studies

We’ve helped orthopedic innovators navigate complex clinical pathways — from novel biomaterials to first-in-human startup studies. With deep orthopedic insight and a global site network, QbD Clinical is your partner in delivering safe, effective musculoskeletal solutions to patients — faster and with full regulatory confidence.

Degenerative  &  Inflammatory Knee Trials

Conditions: Non‑inflammatory degenerative knee disease, osteoarthritis, necrosis, post‑traumatic arthritis, rheumatoid arthritis, knee replacement surgery
Studies: Three PMCF observational studies; two studies currently recruiting; one study enrollment completed
Sites: Up to 4 sites combined (Belgium · Germany)
Participants: 511 participants combined
Key Services:
- Project Management
- Regulatory Submissions
- Monitoring
- Biostatistics
- Data Management & EDC

Looking to support your knee PMCF program? Get in touch!

Osteoarthritis Hydrogel FIH & PMCF Study

Indication: Knee osteoarthritis
Intervention: Intra‑articular hydrogel injections
Studies: First‑in‑Human study in start‑up collaboration; post‑market follow‑up
Sites: Up to 3 sites (Belgium)
Participants: ~30 participants forecasted
Key Services:
- Full CRO Services
- Regulatory Submissions
- Medical Writing
- Safety (incl. CEC & DSMB) & Data Management (E. EDC)

Ready to launch your OA hydrogel trial? Let’s talk!

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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Schedule a meeting

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

Webinar

PMS & PMCF Compliance for Medical Devices Under EU MDR

Join our expert-led webinar series on September 9 and 23 and discover how to turn PMS & PMCF compliance into clinical and strategic advantage — with exclusive insights from a notified body.

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.

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Your CRO for Orthopedic Medical Devices