Industry Leaders, Regulators Headline AAMI-FDA Standards Conference
Attendees of the joint AAMI/U.S. Food and Drug Administration (FDA) International Conference on Medical Device Standards & Regulation can expect an informative two-day event that will gather together industry experts and agency leaders.
The conference, which will take place at the Hyatt Dulles Hotel in Herndon, VA, outside Washington, D.C., March 20-21, will provide up-to-date, detailed information about some of the latest standards and regulatory initiatives that affect medical device manufacturers—both in the United States and abroad.
AAMI has posted the conference agenda on its website. Presenters confirmed thus far include the FDA’s William Maisel, chief scientist and deputy director for science at the Center for Devices and Radiological Health (CDRH), who will discuss the center’s activities and priorities.
In addition, Joe Bhatia, president and chief executive officer of the American National Standards Institute, will be on hand to examine China and the importance of the global standards market. In a separate session, Sherman Eagles of SoftwareCPR will join Kevin Fu, assistant professor in the Department of Computer Science at the University of Massachusetts Amherst, and Bakul Patel, policy advisor, office of the center director, CDRH, to discuss cybersecurity considerations.
Joe Lewelling, vice president of standards development at AAMI, and Dan Ryan, standards technical panel chair at UL (Underwriters Laboratories, Inc.), also will take the stage to discuss challenges and potential standards solutions for interoperability.
Many more experts are slated to speak at the event. For more information and to register, please click here.
Posted: January 11, 2013