Experts in Medical Device Clinical Trials

    QbD Clinical is a European expert specializing in clinical trials for medical devices. We partner with companies worldwide, ensuring they meet the highest quality and safety standards, from concept to patient.

    We bring passion to everything we do, whether it’s a brief consultation or a full-service clinical trial.

     

    Why choose QbD Clinical?

    With over 10 years of experience, QbD Clinical delivers flexible, tailored clinical solutions to help bring medical devices to market efficiently while ensuring compliance with MDR and ISO 14155.

     

    Clinical-CTA

     

     

    Clinical Safety Management - Clinical - QbD Group

    Experts in Medical Device Clinical Trials

    QbD Clinical is a European expert specializing in clinical trials for medical devices. We partner with companies worldwide, ensuring they meet the highest quality and safety standards, from concept to patient.

    We bring passion to everything we do, whether it’s a brief consultation or a full-service clinical trial.

     

    Why choose QbD Clinical?

    With over 10 years of experience, QbD Clinical delivers flexible, tailored clinical solutions to help bring medical devices to market efficiently while ensuring compliance with MDR and ISO 14155.

     

    Clinical-CTA

     

     

    52 +

    Therapeutic indications

    250 +

    Clients worldwide

    45 +

    Countries covered

    650 +

    Projects delivered

    2,400 +

    Clinical sites

    Key Therapeutic Areas

     

    We have in-depth expertise in the challenges associated with medical devices, with a focus on cardiology, vascular, neurology, and orthopedics.

    Unlike CROs that primarily work with pharmaceuticals, we specialize exclusively in medical device clinical trials, offering expert support tailored to your needs.

    Cardiology

    • Heart failure
    • Acute coronary syndromes
    • Atrial fibrillation
    • Coronary artery disease
    • Hypertension
    • Others

    Vascular

    • Peripheral arterial disease
    • Aortic aneurysms
    • Carotid artery disease
    • Venous thromboembolism
    • Pulmonary hypertension
    • Others

    Neurology

    • Alzheimer's disease
    • Parkinson's disease
    • Multiple sclerosis
    • Epilepsy
    • Stroke
    • Others

    Orthopedic

    • Osteoarthritis
    • Rheumatoid arthritis
    • Spinal disorders
    • Fracture repair
    • Others

    Our Services for Medical Devices

    QbD Clincial offers a comprehensive suite of services tailored to address the unique needs of medical device manufacturers.

    Explore our services
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    Quality Assurance

    • Implementation of FDA, EMA, FAHMP, and ISO standards (ISO13485, ISO14971, etc.)

    • Internal and external audits by certified lead auditors.

    • Lifecycle management for Medical Device Software and digital health solutions.
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    Clinical Services

    • Strategy and protocol development for clinical evidence generation.

    • Site selection, monitoring, and regulatory support.

    • Comprehensive medical writing, incl. scientific validity reports and post-market clinical follow-up documentation.
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    Regulatory Affairs

    • CE Marking, FDA clearance, and market entry strategies.
    • Technical documentation and submission packages for MDR and global markets.

    • PRRC services, in-country representation, legal representation, and post-market regulatory support.
    Learn more
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    Take your medical device to the next level with QbD Clinical

    Complete our booking form, and we’ll be in touch shortly to support your requirement.

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