Explore services by industry
    Clinical Solutions for Medical Devices, IVD and CDx – End-to-end clinical support for MedTech innovators

    Clinical Solutions for Medical Devices, IVD and CDx

    End-to-end clinical support for MedTech innovators

    End-to-end clinical support that helps MedTech innovators move from early strategy to regulatory-ready execution — with confidence, speed and compliance. We support medical device, IVD and CDx developers with integrated clinical strategy, study design and trial execution.

    End-to-end clinical delivery

    From gap assessment to full CRO delivery, we support medical device, IVD and CDx developers with integrated clinical strategy, study design and trial execution.

    Clinical Trial Application

    Our experts ensure clinical evidence meets MDR, IVDR and performance evaluation requirements, without late-stage surprises.

    Focused expertise for MedTech innovators

    As a full-service CRO, we guide you from early evidence planning through clinical operations and post-market activities.

    Industry context

    What Are the Biggest Clinical Solutions for Medical Devices, IVD and CDx Challenges?

    At QbD Group, we deliver clinical development and validation for MD, IVDs and CDx, combining high-quality gap assessments, expert medical writing and full-service CRO execution.

    Whether you're preparing a first clinical investigation, generating post-market evidence, or navigating the complexities of companion diagnostic co-development, our multidisciplinary team ensures your clinical program is designed for regulatory success from day one.

    QbD Group expertise

    Why QbD Group

    Why Choose QbD Group for Clinical Solutions for Medical Devices, IVD and CDx?

    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.

    Crédit d'Impôt Recherche (CIR) accreditation logo

    CIR accreditation 2026 to 2028

    CIR-accredited research partner in France

    QbD Group is accredited by the French Ministry of Higher Education, Research and Space as a research organisation under the Crédit d'Impôt Recherche (CIR) scheme for 2026 to 2028. Eligible R&D services you subcontract to QbD Group can therefore be included in your CIR declaration.

    This applies to French companies, and to foreign companies with a subsidiary or permanent establishment in France, that are eligible for the CIR scheme.

    Contact us