Navigating Regulatory with Monica Ferrante

18/02/2019

MedTech Mindset

0:00

47:01

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

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Navigating Regulatory with Monica Ferrante
18/02/2019
47:01
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
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Navigating Regulatory with Monica Ferrante

MedTech Mindset

D'autres épisodes de "MedTech Mindset"

#14: Breaking Barriers in MedTech Fundraising

#13: Medical Device Design Meets Value Analysis with Mark Copeland

Maintaining Agility & Quality in Device Software Development with Rightley McConnell

Data Flow Medtech Innovation with Seth Goldenberg

Securing Funding with Adam Dakin, Part II

Securing Funding with Adam Dakin, Part I

Staking Your IP Claim with Gregory Bernabeo

Overcoming Pediatric Device Innovation Challenges with Matthew Maltese

Navigating Regulatory with Monica Ferrante

Branding in MedTech with Bill Gullan