
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 | 182 | Founded | 6 months ago |
|---|---|---|---|---|---|
| Number of Listeners | Categories | TechnologyLife SciencesScience | |||

In this episode of MedTech Global Insights, we dissect the FDA's unexpected new mandatory cybersecurity rules for connected medical devices. What was once guidance is now a critical requirement for market access, demanding continuous post-market surv... more
The global MedTech landscape is shifting, and the recent MedTech World conference in Dubai just sent some powerful signals about the future. This episode unpacks the key trends, investment clues, and strategic insights from the heart of the Middle Ea... more
This week, we dissect the monumental shift in the US market as the FDA's new Quality Management System Regulation (QMSR) takes full effect. This move, which aligns US regulations with the global ISO 13485 standard, is being celebrated as a major step... more
The U.S. FDA has just enacted its most significant regulatory overhaul in decades, replacing the old Quality System Regulation (QSR) with the new Quality Management System Regulation (QMSR). This major shift harmonizes the FDA's framework with the in... more
The game has changed. This week, the US FDA implemented a 'Total Product Life Cycle' inspection model, shifting regulatory focus from a one-time market approval to a continuous, career-long scrutiny of your medical device. This episode of MedTech Glo... more
This episode of MedTech Global Insights dives into the critical February 2026 deadline for the FDA's new Quality Management System Regulation (QMSR). We explore why this major regulatory shift is more than just an alignment with the ISO 13485 interna... more
Last week, the FDA sent a clear message to the MedTech industry by halting a major device submission over cybersecurity flaws. This episode of MedTech Global Insights dissects the new reality of the FDA's "Refuse to Accept" policy and what it means f... more
The FDA's new cybersecurity rules are more than just a regulatory checklist; they're reshaping the landscape for MedTech investment and acquisitions. Many innovative startups are discovering that their market access and company valuation now hinge en... more
How this podcast ranks in the Apple Podcasts, Spotify and YouTube charts.
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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 6 months ago and published 182 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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