TENTANG EPISODE INI
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 versus Europe’s annual surveillance audits, we dig into what medical device companies really need to know before entering either market.
Whether you’re a startup navigating your first clearance or a seasoned RA/QA pro, this is your crash course on how regulators (and auditors) think—and why it matters for your compliance strategy.
Watch the video version on YouTube: https://youtu.be/JbuFPVBuB-4
Inggris
Amerika Serikat
TRANSKRIP 🔗
Are you the producer of this podcast?
Add a podcast transcript
Need Audio-to-Text?
Transcribe with Listen411 in Just 60 Seconds
CARI EPISODE TERDAHULU
Cari episode sebelumnya dari RAQA Today.
EPISODE LAIN DALAM PODCAST INI
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 competitive advantage.
From shocking stories of last-min…
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 to understand to survive regulatory conversatio…
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 shaping medtech.
What you’ll learn in this episod…
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 administration’s sweeping deregulation mandates to the long-awa…
Sanggahan: Podcast dan karya seni yang disematkan pada halaman ini berasal dari Michelle Lott, yang merupakan milik pemiliknya dan tidak berafiliasi atau didukung oleh Listen Notes, Inc.
Sunting
Terima kasih telah membantu agar basis data podcast tetap terbaru
