Larissa D’Andreadandrea
Director, Government and Regulatory Affairs
ResMed

 

Larissa will be one of the distinguished presenters at the 6th Annual Medical Device Regulatory Affairs: Securing Clearance & Maintaining Compliance Conference.

 

Why is the 6th Annual Medical Device Regulatory Affairs: Securing Clearance & Maintaining Compliance Conference important to regulatory affairs executives?
The topics are timely, relevant and with great speakers from across industry.

 

How has Regulatory Affairs evolved in the last several years? 
As products continue to become more complex, the antiquated regulatory framework does not enable innovation, particularly in the Digital health space where the pace of innovation is rapid.

 

Not registered for the Medical Device Regulatory Affairs: Securing Clearance & Maintaining Compliance Conference yet? Check out some of the highlighted sessions:

  • Understanding the 510k Reform & Guidelines for New and Legacy Products
    Led by Paul Swift, Director, Global Regulatory Affairs at Alcon and Marjorie Shulman, Director, Premarket Notification 510(k) Program with the FDA
  • A Case Study on Preparing for FDA Inspections to Meet the Increasing Regulatory Demands
    Led by Vy Tran, Senior Vice President of Regulatory Affairs and Quality Systems at Varian Medical Systems
  • The Industry Response & Preparation for EU Re-registration for CE Marked Devices
    Gert Bos, PhD, FRAPS, Director of the Board, RAPS, the Netherlands and Hilde Viroux, Global Head EU MDR Compliance at Alcon