Navigating Regulatory with Monica Ferrante
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