
What's next in the future of health? Welcome to MedTech Global Insights, the podcast dedicated to uncovering the most disruptive technologies and brilliant minds in the medical field. Whether you're an industry professional, investor, or simply curious, subscribe for your dose of cutting-edge information and expert commentary.
| Publishes | Daily | Episodes | 126 | Founded | 4 months ago |
|---|---|---|---|---|---|
| Number of Listeners | Categories | Life SciencesScienceTechnology | |||

Brazil has just opened a regulatory fast-track for AI medical devices, promising market approval in just 90 days. This is a massive opportunity for MedTech companies looking to expand into Latin America, but a hidden challenge is causing significant ... more
Brazil's health authority, ANVISA, recently announced an exciting fast-track approval pathway for AI and machine learning medical software. This move promises to accelerate market access in one of Latin America's biggest markets, creating a massive o... more
Last week, the European Commission extended the challenging IVDR transition deadlines, giving diagnostic manufacturers more time. While this seems like a reprieve, it introduces significant strategic complexity and the dangerous risk of complacency. ... more
The European Commission has ended years of uncertainty by announcing a mandatory deadline for EUDAMED. As of May 28, 2026, medical device and IVD companies must comply with the database's core modules. This isn't just a new database; it's a new era o... more
This week, we unpack the major implications of the UK MHRA's landmark approval of GSK's new twice-yearly asthma treatment. This is more than a product launch; it's a crucial signal for the global MedTech industry on how to successfully navigate the c... more
Last week, the FDA unveiled a game-changing fast-track for AI diagnostics, but a hidden challenge is already causing chaos for unprepared companies. We break down the new 'Agile PMS' framework and what it means for your market access strategy.
This ... more
The US FDA is making its biggest change to quality system regulations in a generation, harmonizing with the global ISO 13485 standard. This shift, mandated by the new Quality Management System Regulation (QMSR), presents both opportunities for stream... more
The promise of AI in MedTech is undeniable, but a major regulatory storm is brewing in the European Union. A new, complex dual-compliance framework now requires AI-driven medical devices to satisfy both the rigorous Medical Device Regulation (MDR) an... more
How this podcast ranks in the Apple Podcasts, Spotify and YouTube charts.
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Apple Podcasts | #217 |








Listeners, social reach, demographics and more for this podcast.
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Content focuses on regulatory compliance, quality management, and risk management in the medical technology sector, emphasizing the complexities of navigating the evolving landscape of medical device regulations. Episodes frequently address global standards such as ISO 13485 and ISO 14971, alongside recent changes in FDA regulations, particularly relevant for software as a medical device (SaMD) and artificial intelligence. The discussions incorporate real-world case studies and expert insights, making it particularly valuable for professionals in the MedTech industry seeking to understand compliance challenges and market access strategies.
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MedTech Global Insights launched 4 months ago and published 126 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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Recent guests on MedTech Global Insights include:
1. Pure Global
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