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MedTech Global Insights

Ran Chen
FDA
Medical Devices
Global Regulatory Strategy
Regulatory Compliance
Post-Market Surveillance
FDA De Novo Pathway
Global Market Access
MDR (medical Device Regulation)
Global Regulations
Artificial Intelligence
Cardiovascular Devices
CE Mark
Medical Device Regulation
Data Privacy
Cybersecurity
Software As a Medical Device
Brazil
South Korea
Technical Dossier
Artificial Intelligence In Healthcare

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.

PublishesDailyEpisodes126Founded4 months ago
Number of ListenersCategories
Life SciencesScienceTechnology

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Artwork for MedTech Global Insights

Latest Episodes

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

Key Facts

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Recent Guests

Pure Global
A firm providing regulatory consulting services in Brazil for MedTech companies
Pure Global
Episode: Unlocking Brazil's MedTech Market: Your Guide to ANVISA Compliance and Finding the Best Regulatory Consulting Firm with Pure Global

Host

Pure Global Team
The expert team discussing the episode topics, bringing insights on MedTech and regulatory challenges.

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Frequently Asked Questions About MedTech Global Insights

What is MedTech Global Insights about and what kind of topics does it cover?

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.

Where can I find podcast stats for MedTech Global Insights?

Rephonic provides a wide range of podcast stats for MedTech Global Insights. We scanned the web and collated all of the information that we could find in our comprehensive podcast database. See how many people listen to MedTech Global Insights and access YouTube viewership numbers, download stats, audience demographics, chart rankings, ratings, reviews and more.

How many listeners does MedTech Global Insights get?

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What are the audience demographics for MedTech Global Insights?

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How many subscribers and views does MedTech Global Insights have?

To see how many followers or subscribers MedTech Global Insights has on Spotify and other platforms such as Castbox and Podcast Addict, simply upgrade your account. You'll also find viewership figures for their YouTube channel if they have one.

How many episodes of MedTech Global Insights are there?

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.

How do I contact MedTech Global Insights?

Our systems regularly scour the web to find email addresses and social media links for this podcast. We scanned the web and collated all of the contact information that we could find in our podcast database. But in the unlikely event that you can't find what you're looking for, our concierge service lets you request our research team to source better contacts for you.

Where can I see ratings and reviews for MedTech Global Insights?

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What guests have appeared on MedTech Global Insights?

Recent guests on MedTech Global Insights include:

1. Pure Global

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