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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
Cybersecurity
Data Privacy
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.

PublishesDailyEpisodes137Founded5 months ago
Number of ListenersCategories
Life SciencesScienceTechnology

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Artwork for MedTech Global Insights

Latest Episodes

In this episode, we dissect the U.S. FDA's landmark decision from the first week of January 2026 to ease regulations on general wellness and digital health wearables. This policy shift is set to accelerate innovation in the consumer health tech marke... more

This week, we dissect a critical trend impacting the US MedTech landscape: the sustained surge in FDA warning letters. This isn't a random enforcement spike; it's a targeted campaign against systemic weaknesses in Quality Management Systems that many... more

This week, we dissect a critical, under-the-radar policy shift from the US FDA concerning AI and machine learning medical devices. Regulators are cracking down on Predetermined Change Control Plans (PCCPs), demanding a level of detail that many compa... more

This week, MedTech Global Insights dives into the US FDA's groundbreaking new final guidance on Predetermined Change Control Plans (PCCPs) for AI-enabled medical devices. This policy promises to accelerate innovation by allowing pre-approval for futu... more

In this episode, we dissect the recent FDA De Novo approval of a revolutionary AI diagnostic tool for oncology. While the industry celebrates this milestone, we look beyond the headlines to uncover the complex and demanding post-market challenges tha... more

This week, MedTech Global Insights dives into the FDA's game-changing final rule to regulate Laboratory Developed Tests (LDTs) as medical devices. We unpack the agency's rationale behind this historic policy shift, ending decades of enforcement discr... more

The FDA just dropped a bombshell on the AI medical device world. On January 2nd, they unveiled the 'AI-Driven SaMD Pre-Certification Excellence Program,' or AIPEP. This new pilot program promises a fast track for AI-powered software, but it comes wit... more

In the final days of 2025, the U.S. FDA unveiled a pivotal shift in policy, now allowing broader use of Real-World Data (RWD) in medical device submissions. This episode of MedTech Global Insights unpacks what this means for the industry, from startu... 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 5 months ago and published 137 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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