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  • Medical Device Development

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  • Quintiles Clinical Trial

    Increasing regulatory scrutiny and stakeholder demands can block the launch of your medical device. What’s the most direct route to success?

    With a unique blend of former regulators and industry experts, Quintiles has guided hundreds of medical devices to global market success. Our multidisciplinary teams have helped innovators of virtually every type of therapeutic and diagnostic device in all major world markets. 

    Strategies to drive medical device development across the full lifecycle

    • Concept development and refinement to optimize value
    • Clinical plan development for medical device trials to capture the right evidence for key stakeholders 
    • Quality system design to ensure medical device compliance 
    • Global regulatory pathway mapping and support including document preparation and submission 
    • Market access and reimbursement strategy 
    • Post-market surveillance and product stewardship

  • Leading expertise that meets your global launch challenges 

  • Quintiles Clinical Trails

    Additional focus in the EU has been placed on clinical evaluations reports since changes in the Medical Devices Directive [“MDD”] have come into force in March 2010 Read factsheet

  • Quintiles Clinical Trails

    Registering an OTC product as a medical device can provide a faster and more cost-effective way of entering the European market, according to Quintiles’ Dr Peter Lassoff. Read article