Medical Devices, In Vitro Diagnostics, and Combination Products Track at DIA2013

What are the major risks/impact of new regulatory initiatives on medical device approvals?

How do I apply regulatory strategies in co-development of Companion Diagnostics? Are you looking for a cost-efficient, speed to market Adaptive Design Clinical Trial Model? What can I do to foster regulatory body relationships to ensure timely approvals? What are the pros/cons of the FDAMA de novo petition process? What can I expect from FDA CDRH after MDUFA? What are the global challenges to market products in EU and BRIC countries? What are the Postmarket Surveillance Issues for medical devices?   Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.