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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
Brazil
CE Mark
Medical Device Regulation
Data Privacy
Cybersecurity
Software As a Medical Device
South Korea
Technical Dossier
Regulatory Approval Process

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.

PublishesDailyEpisodes182Founded6 months ago
Number of ListenersCategories
TechnologyLife SciencesScience

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Artwork for MedTech Global Insights

Latest Episodes

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

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 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.

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?

Rephonic pulls ratings and reviews for MedTech Global Insights from multiple sources, including Spotify, Apple Podcasts, Castbox, and Podcast Addict.

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What guests have appeared on MedTech Global Insights?

Recent guests on MedTech Global Insights include:

1. Pure Global

To view more recent guests and their details, simply upgrade your Rephonic account. You'll also get access to a typical guest profile to help you decide if the show is worth pitching.

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