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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
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
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.
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