Industry Leaders, Regulators to Headline
AAMI/FDA Standards Conference

An impressive lineup of experts will provide updates on the regulatory process for the medical device industry, as well as shed light on challenges and opportunities abroad during the 23rd AAMI/FDA International Conference on Medical Device Standards and Regulation.

The two-day event—taking place in Herndon, VA, near Washington, D.C.’s Dulles International Airport—will bring together more than 150 representatives from the FDA, medical device manufacturers, and other organizations. Anyone who is responsible for complying with medical device standards and regulations is encouraged to attend the March 20-21 event.

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 and their impact on the medical device industry. Attendees will receive updates on the 510(k) process, the Innovation Pathways initiative, which works to help bring safe, breakthrough medical products to patients in a timely manner, and much more. 

Also slated to attend is Joe Bhatia, president and chief executive officer of the American National Standards Institute, who will examine China and the importance of the global standards market.

Participants also will learn how recent changes to the European Medical Device Directive (MDD) will influence the international marketplace. Many industry experts think these changes will have a big impact, and Elisabeth George, vice president of global government affairs, regulations, and standards, Philips Healthcare, Jürgen Stettin of Prosystem AG, and Oliver Christ, Prosystem AG, will take the stage to address challenges and concerns.

“There are profound changes proposed in the regulation of medical devices in Europe,” says Eamonn Hoxey, vice president of regulatory compliance/medical devices and diagnostics with Johnson & Johnson and co-chair of AAMI’s Committee on Standards Strategy and member of AAMI’s Board of Directors. “While the implementation of revised legislation takes some time, it is important for all manufacturers who supply the European market to understand the direction that is being taken in order to be able to adapt to any changed requirements in time. Potential changes go across the lifecycle of a medical device—the oversight of clinical studies; the way that Notified Bodies are overseen and how they operate, such as conducting unannounced audits; more rigorous premarket review of highest risk devices; greater expectations and coordination of postmarket surveillance; and greater transparency of information on the regulatory processes.”

In a separate session on cybersecurity, Sherman Eagles, partner at 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 current concerns.

Joe Lewelling, vice president of standards development at AAMI, Dan Ryan, standards technical panel chair at UL (Underwriters Laboratories, Inc.), and Terenzio Facchinetti, PhD, business development manager for UL Life and Health Business Unit, also will take the stage to discuss challenges and potential standards solutions for interoperability.

These topics, along with an update on the activities of the International Medical Device Regulators Forum, which has taken the place of the Global Harmonization Task Force, will be covered during the conference. 
For more information and to register, please click here. A conference agenda is also available here.

AAMI, the Association for the Advancement of Medical Instrumentation, is a nonprofit organization founded in 1967. It is a diverse community of nearly 7,000 healthcare technology professionals united by one important mission—supporting the healthcare community in the development, management, and use of safe and effective medical technology.