Process Validation Procedures, UDI Plans, De Novo Submissions Among Session Topics on Agenda


(Chicago, IL) – The most popular conference for medical device regulatory professionals is back with new sessions, more insights, and more opportunities for networking and idea sharing. The 5th Annual Medical Device Global Regulatory Intelligence Conference will be held in Alexandria, Virginia, July 27-28, 2015, offering conference attendees an opportunity to address some of the top concerns in the regulatory space such as rolling out UDI for Class II products, transitioning from MDD to MDR, and more.


Two dozen of the most successful and influential leaders in the regulatory space will be on hand to present sessions, case studies, panels, and workshops, including Kerri-Ann Arnott of Johnson & Johsnon, Tamima Itani of Boston Scientific, and Paul Brooks of BSI Group. Conference participants will be able to obtain insight on a wide variety of topics on both the domestic and international regulatory levels such as global UDI standards, updates to EU medical device regulations, and the future of the 510K program.


Carol Clark-Evans of BTG International, Inc, presenter and previous attendee, said she was a fan of the conference platform for its intimate sharing and networking opportunities.


Major changes within the industry will be discussed, with panel discussions on mobile medical healthcare, the impact of a collaborative and transparent relationship between FDA and the medical device industry, and overcoming inconsistencies in FDA reviewer feedback. Conference delegates will also receive an inside look at global regulations surrounding the UDI standard, EU updates to device regulations, and preparing for the transition from MDD to MDR. Plenty of networking opportunities will be offered throughout the event.


For more information on the 5th Annual Medical Device Global Regulatory Intelligence Conference, please visit, or contact You can also follow the conference on Twitter, @Q1Productions, #DeviceReg15.