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Your CRO for Neurology Medical Devices

Your CRO for Neurology Medical Devices

Specialized support for clinical research in neurology 
 

At QbD Clinical, we understand your mission: delivering transformative neurology medical devices to patients safely and efficiently. That’s why we don’t just manage clinical trials; we partner with you to drive meaningful outcomes. 

As a European CRO focused exclusively on medical devices, we bring deep expertise in Neurology Medical Device clinical research. From neurostimulation and diagnostic imaging to stroke intervention and neurodegenerative disease technologies, we support your journey from strategy to post-market follow-up. 

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

Our CRO Services for Neurology 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

Your CRO for Neurology Medical Devices  (1)

Why Choose QbD Clinical for Neurology Trials?

The right CRO for complex, high-impact neurological innovation. 

  • Neurology Expertise
    We support Class IIb and III devices with deep therapeutic knowledge across neurological conditions such as Alzheimer’s, Parkinson’s, multiple sclerosis, epilepsy, and stroke.
  • 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 neurology 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. 
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Featured CRO Case Studies

We bring hands-on expertise to complex neurological studies — from early feasibility to pivotal trials and post-market surveillance. Our team has supported a wide range of neurology-focused medical device trials, including technologies for stroke intervention, neurodegenerative diseases, epilepsy, and neurostimulation. 

With deep therapeutic insight, global site partnerships, and flexible CRO services, we help medtech innovators navigate regulatory complexity and bring life-changing neurological solutions to patients — faster, safer, and with full compliance. 

Depression VNS Therapy Pilot

Depression

  • Therapy: VNS therapy (Vagus Nerve stimulation)

  • Study: Post‑market study (currently recruiting)

  • Sites: Up to 15 sites across Europe

  • Participants: 202 enrolled

  • Key Services:
    • Project Management
    • Monitoring
    • Local Resources
Epilepsy Neuromodulation Study

Epilepsy

  • Therapy: Neuromodulation

  • Study: Post‑market close‑out study

  • Sites: 60 sites (Europe · Middle East · North America · Asia · Australia)

  • Participants: 827 enrolled

  • Key Services:

    • Project Management

    • Monitoring

Stroke Aspiration Thrombectomy Trial

Stroke

  • Procedure: Aspiration thrombectomy

  • Study: Prospective, interventional (recruitment complete; in follow‑up)

  • Sites: Up to 24 sites (Europe · US)

  • Participants: 246 enrolled

  • Key Services:

    • Full CRO Services

    • Regulatory Submissions

    • Safety (CEC & DSMB) & Data Management

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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.

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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
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Josie Rose

Sr. Pharmaceutical Strategist
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Josie Rose

Sr. Pharmaceutical Strategist
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Let’s Talk About Your Trial

Whether you’re refining your clinical strategy or launching a pivotal neurology trial, we’re here to help.
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Resources

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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.
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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.
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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.
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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!
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.