Navigating Regulatory with Monica Ferrante

MedTech Mindset

English - February 18, 2019 05:00 - 47 minutes - 21.6 MB - ★★★★★ - 11 ratings
Technology Business medtech medical device engineering design medical technology healthcare archimedic smithwise diagnostics wearable tech Homepage Download Apple Podcasts Google Podcasts Overcast Castro Pocket Casts RSS feed

Previous Episode: Branding in MedTech with Bill Gullan

Next Episode: Overcoming Pediatric Device Innovation Challenges with Matthew Maltese

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 pathwaysHow FDA is changing in recent yearsTrends in regulation--are medical devices under-regulated by FDA?Formal vs. informal pre-submission meetings with FDAHow to go about finding trustworthy regulatory support