
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 | 159 | Founded | 5 months ago |
|---|---|---|---|---|---|
| Number of Listeners | Categories | TechnologyLife SciencesScience | |||

This week on MedTech Global Insights, we dissect the wave of "Refuse to Accept" letters from the US FDA that are derailing market entry plans. As the agency fully enforces its new cybersecurity mandates, many MedTech companies are finding their submi... more
The game has changed for MedTech approvals. Following a recent FDA alert, data from third-party testing labs is now under intense scrutiny, creating a hidden barrier to market access. This episode of MedTech Global Insights explores the rising threat... more
This week, we dissect the FDA's landmark final rule, which replaces the decades-old Quality System Regulation (QSR) with the new Quality Management System Regulation (QMSR). This significant move aligns US requirements with the global ISO 13485 stand... more
The European Commission has proposed another extension to the IVDR transition deadlines, offering a potential lifeline to the diagnostics industry. However, this relief comes with a critical catch that could mislead unprepared manufacturers into a fa... more
The U.S. FDA has just released new draft guidance on AI-powered Clinical Decision Support (CDS) software, sending a wave of uncertainty across the MedTech industry. This episode of MedTech Global Insights breaks down what this sudden shift means for ... more
This week on MedTech Global Insights, we dissect the latest regulatory tremor from the European Union. A new draft guidance on AI-powered medical software has just been released, and it’s sending ripples through the industry by fundamentally changing... more
The EU's AI Act is creating a new, complex layer of regulation for MedTech companies, especially for those with AI-powered software. A device fully compliant with the Medical Device Regulation (MDR) could now be deemed a "high-risk AI system," demand... more
This week on MedTech Global Insights, we dissect the FDA's aggressive new enforcement on medical device cybersecurity. As regulators begin to treat digital vulnerabilities as critical safety failures, the rules for market access have fundamentally ch... 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 5 months ago and published 159 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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