Information Library
Results for: Brochures - Medical Devices - Regulatory
To learn more about Quintiles’ services, you may broaden or narrow your search by selecting the topics at left.
- Sort by:
- Recently Added
- Title
-
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.
Page 1 of 1 (2 results)
