Medical Device Diagnostic Expertise

Guires offers strategic clinical trial support for new diagnostic devices and indications of all risk classes, including active implantable devices, combination products and implants throughout a wide range of therapeutic areas.

Our support encompasses simple healthy sample collection and rigorous investigation device exemption (IDE) trials, as required by the U.S Food and Drug Administration. Our experts include experienced physicians who apply their knowledge and experience to review your;

• protocol, identify the patient population,
• Clinical Study Design & Execution: Guided by Clinical Strategist biostatisticians, Data management, who help in preparation of statistical analysis Clinical Report, literature review, CER, dossiers and
  • Commercialization & outcomes,
    • Health Economics,
    • Clinical outcome assessment,
    • Epidemiology,
  • Provide specific guidance on your regulatory process.
  • Strategic resourcing
    • Functional Service provision, Contract & Permanent.
    • Placement, Executive Search.
    • Dedicated Device-specific Project Managers Worldwide.

  Our therapeutic experience in devices and diagnostics with an indication in

  • Diabetes management technologies include testing, treatment, and device monitoring
    • Glucose monitoring system, insulin delivery system, intravenous blood glucose monitoring systems, insulin dose calculation software, neuropathy detection and monitoring technologies
  • Orthopaedics
  • Cardiovascular disease
    • Angiogenesis
    • Angioplasty (PTCA)
    • Artery Closing
    • Arrhythmia Ablation
    • Cardiac Pacemakers
    • Cardiac Defibrillators
    • Cardiac Imaging
    • Cardiogenic Shock
    • Circulatory Assist
    • Gene Therapies / Stem Cell Therapies
    • Radiation Therapies
    • Stents (Coronary / Peripheral Endovascular / Drug Eluting)
    • Congestive Heart Failure
    • Ventricular Assist Devices (VADs)
    • Surgeries such as Angioplasty (PTCA) Coronary Artery ByPass Graft (CABG)
  • Dental and maxillofacial
  • Respiratory
  • Diagnostic Imaging Experience
  • Blood Banking
  • Medical device software, wireless systems, and mobile medical applications
  • OTC and consumer products
  • IVDs and companion diagnostics