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RAPS Convergence 2020

RAPS 2020 Convergence is going virtual this September! We’re sorry that we won’t be able to meet with you in person in San Antonio, Texas this year but we look forward to participating and interacting with everyone online.  Let us know if you would like to setup a private Zoom meeting to discuss your project.

RAPS 2020 ConvergenceBe sure to join us on Monday September 14, 10:00am-10:30am EDT, when David Gross, Director of MRI Safety Evaluations, will be giving a presentation on, “How can Modeling and Simulation be used to Support MRI Safety Labeling of Medical Devices?”  It is important for individuals involved in regulatory affairs to have an awareness of how modeling and simulation can be used to augment or replace MRI safety testing to meet labeling requirements for medical devices. Participants will be made aware of the fundamental MRI safety concerns (i.e., force, torque, image artifact and RF heating), as well as the corresponding standard test methods.  They will also learn how modeling and simulation can be used to find worst-case constructs and for developing the necessary scientific rationale to support MRI safety labeling reported in the instructions for use (IFU) for medical devices. In addition to these key points, participants will learn how the labeling requirements have changed and how to implement these changes in upcoming regulatory submissions.

It is our goal that the following learning objects are met after attending this presentation:

  1. Attendees will be able to describe how modeling and simulation can be used to augment or replace physical MRI testing for the purposes of MRI labeling in the IFU.
  2. Attendees will be able to describe the primary MRI safety considerations for labeling in the IFU.
  3. Attendees will be able to explain the “state-of-the-art” for MRI labeling information and format, and understand the recent changes.

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