Event Details

Sara Dyson to Speak at MedTech Intelligence Conference on Medical Device Recalls

May 14, 2018 - May 15, 2018

Washington, DC

Many changes are coming that will affect risk and health hazard determination and the practical conduct of recalls and other field actions.  Center and Field reorganization, new HHE procedures, UDI implementation, the rollout of tools for benefit assessment and the use of real world evidence and OUS data on device performance, Case for Quality and TPLC alignment, and more.

Join the sixth annual MedTech Intelligence Medical Device Recalls conference for presentations, panel discussions, and networking with senior FDA and industry experts to learn about recent and upcoming changes and their practical impact on how companies manage the decision-making and execution of recalls.

What you will learn:

  • New FDA initiatives affecting recalls
  • New HHE procedures
  • UDI implementation and OUS mandates
  • Practical approaches to benefit-risk calculation
  • Data sources for device performance assessment
  • The hospital perspective on recall communications
  • Special recall issues with diagnostics, radiology, and software
  • Product liability implications of recalls
  • Best practices for recall termination
  • The challenges of global recalls

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