The annual AAMI/FDA International Conference on Medical Device Standards and Regulation has undergone some new and exciting enhancements, and has been given a new mission and a new name: S3 Challenge 2014: The AAMI/FDA Forum on Standards, Synthesis, and Solutions will be held March 11-12, 2014 at the Hyatt Dulles in Herndon, Va., near Washington, D.C.’s Dulles International Airport.
The conference will enable leaders from industry and government to collaborate on the most pressing issues related to the use of medical technology standards, to formulate solutions that will result in safer and better-performing medical devices, and to reduce the time it takes to bring new devices to market.
The two-day event will be organized into four half-day sessions on biocompatibility, risk management, sterility, and the vertical application of all three to a specific type of device. Each session will begin with presentations by standards development experts and the FDA on the current challenges surrounding the topic being discussed, what information the FDA needs in order to complete a premarket review, and what standards are available to guide safety and compliance with FDA regulatory requirements. In addition, each session will feature an extended open discussion among all conference attendees on a range of issues, including whether some standards could be improved or whether there are gaps that could be addressed by new standards. This is an invaluable opportunity for you to fully communicate your organization’s perspective on the issues that complicate standards and compliance—and then brainstorm with industry colleagues and FDA staff to recommend actions that can make standards more workable and implementation more consistent.
For full details and to register, call 1 (800) 373-3174.