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Results for: Medical Devices
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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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