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RAQA Today

Michelle Lott

Podcast by Michelle Lott

PublishesTwice weeklyEpisodes64Founded4 years ago
Number of ListenersCategory
Business

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Latest Episodes

Because your QMS should be a safety net—not a set of handcuffs.

In this episode of Device and Conquer, Michelle and Ti break down how to build a quality management system (QMS) that doesn’t suck—or suck the life out of your MedTech team.

From the ... more

If you’re thinking about investing in medtech, congratulate yourself—you’ve chosen one of the most exciting, innovative, and occasionally stomach-churning sectors out there.

But between regulatory hurdles, clinical workflow quirks, and the fact tha... more

Choosing a predicate device can make—or break—your 510(k) submission, so it's important to choose wisely.

In this episode of Device and Conquer, Michelle Lott and Ti Benson break down one of the trickiest parts of the FDA clearance process: how to s... more

Building a 510(k) isn’t just about filling in forms — it’s about telling the FDA a story they can’t say no to.In this episode of Device & Conquer, Michelle Lott and Tianna Benson unpack what really goes into preparing an FDA 510(k) submission — from ... more

The FDA pre-submission (Q-Sub) process can save you time — or sink your submission. In this episode of Device and Conquer, Michelle Lott and Tianna Benson explain how to Pre-Sub like a pro.

They explain when to use a pre-sub, how to structure your q... more

The FDA state of the union in 2025 - deregulation, QMSR, and a toilet paper shortage?

Listen in as Michelle Lott and Tianna Benson tackle the wild world of FDA policy shifts and what they mean for medical device manufacturers. From the administratio... more

Think you speak English? The FDA might disagree.

In the Season 2 kickoff of Device &Conquer, hosts Michelle Lott and Tianna Benson break down the unique language of the U.S. Food and Drug Administration — a dialect every medtech professional needs t... more

In this episode, Michelle and guests take a deep dive into what’s really happening inside the FDA in 2025. From pre-submission strategies to the blurred line between wellness and medical devices, this discussion uncovers the latest regulatory trends ... more

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1. Global Medical Device Podcast powered by Greenlight Guru
2. Let's Combinate - Drugs + Devices
3. Modern Love
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5. Planet Money

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RAQA Today launched 4 years ago and published 64 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.

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