RAQA Today
Michelle LottPodcast by Michelle Lott
| Publishes | Weekly | Episodes | 57 | Founded | 4 years ago |
|---|---|---|---|---|---|
| Number of Listeners | Category | Business | |||
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Latest Episodes
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
In the Season 1 finale, Michelle and Ti challenge the traditional view of regulatory affairs as the “business prevention department.” Instead, they reframe regulators as strategic partners and proactive innovators who can drive compliance and competi... more
In this episode of Device and Conquer, we unpack the differences between the FDA’s inspection style and the EU’s notified body-driven approach.
From classification rules and audit methodologies (QSR, ISO 13485, MDSAP) to unannounced FDA inspections... more
Who really is the FDA and how do they regulate medical devices? In this episode of Device and Conquer, we break down the U.S. Food and Drug Administration’s role—from product classification and product codes to substantial equivalence, 510(k)s, de no... more
In this episode of the NEW Device and Conquer podcast, Michelle and co-host Ti dive deep into the European Union’s Medical Device Regulation (MDR) — and explain why it’s much more than just red tape.
The conversation begins with a fun recap of their... more
What exactly is a medical device — and why does it matter if it’s regulated?
In this premiere episode of Device and Conquer, hosts Michelle Lott and Ti Benson unpack the surprisingly broad world of medical devices, from smart thermometers and gluco... more
In this episode Michelle and Adam Foresman from Ryden Solutions do a deep dive into right-sizing quality systems, lean regulatory practices, and the evolving landscape of AI-driven compliance tools in medtech. They reflect on personal pain points tha... more
The FDA Breakthrough Device Program offers a expedited path to market for medical devices that offer more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions. It allows for prioritized review and enhanced com... more
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| Listeners per Episode | Gender Skew | Location | |||
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Which podcasts are similar to RAQA Today?
These podcasts share a similar audience with RAQA Today:
1. Global Medical Device Podcast powered by Greenlight Guru
2. The Rich Roll Podcast
3. TED Radio Hour
4. The Daily
5. Wait Wait... Don't Tell Me!
How many episodes of RAQA Today are there?
RAQA Today launched 4 years ago and published 57 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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