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Results for: Clinical Services - Medical Devices - Regulatory

In the complex environment of the New Health, Quintiles is committed to helping you succeed. At every stage of your product’s lifecycle, we are dedicated to delivering real results, being proactive in navigating issues and thinking of new solutions.  Search our library today.

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  • Clinical Evaluation Medical Devices

    Brochure — October 6, 2011
    A Clinical Evaluation Report (CER) is a living document required for all classes of new and existing products within the EU, detailing the clinical evaluation of a product throughout its life-cycle. Additional focus has been placed on clinical evaluations since changes in the Medical Devices Directive [“MDD”]1 have come into force in March 2010. A renewed focus by Notified Bodies on clinical evaluations, against the updated legislation, has led to a number of audit observations against manufacturers with regard to CER’s containing insufficient clinical data, or manufacturers not holding product CER’s.

  • Clinical – Smarter Trials, Accelerated Outcomes

    Brochure — February 16, 2011
    Quintiles will work with you to plan and execute the smartest clinical trials and post-marketing studies, informed by a holistic view of strategic, operational, regulatory and marketplace issues.

  • PharmAsia News Article Reprint

    Media Coverage — March 1, 2010
    Quintiles Asia Executives Say CROs Must Evaluate, Adjust To New Health Landscape: An Interview With PharmAsia News.

  • Geoff Garabedian

    Hear from the Experts — March 25, 2009
    As Practice Leader for Regulatory and Quality in the U.S., Geoff combines a strong management consulting background with specific experience in the regulatory and compliance arena, including design and implementation of large-scale process, organization and technology transformations.

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