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Navigating Regulatory with Monica Ferrante

Season #1 Episode #6

In this episode, regulatory expert Monica Ferrante, VP of Regulatory and Quality at Aspire Bariatrics, talks regulatory strategy and approvals for new medical devices coming to market.

Monica and Dan discuss:

  • FDA risk classifications and how to steer down various regulatory pathways
  • How FDA is changing in recent years
  • Trends in regulation--are medical devices under-regulated by FDA?
  • Formal vs. informal pre-submission meetings with FDA
  • How to go about finding trustworthy regulatory support