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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.
Clinical Evaluation Report for Medical Devices
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
Devising OTC Strategies for Devices
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