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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
Technical Dossier
Regulatory Approval Process
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.

PublishesDailyEpisodes159Founded5 months ago
Number of ListenersCategories
TechnologyLife SciencesScience

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Artwork for MedTech Global Insights

Latest Episodes

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The U.S. FDA has just released new draft guidance on AI-powered Clinical Decision Support (CDS) software, sending a wave of uncertainty across the MedTech industry.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 A new draft guidance on AI-powered medical software has just been released, and it’s sending ripples through the industry by fundamentally changing...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

Key Facts

Contact Information
Podcast Host
Number of Listeners
Find out how many people listen to this podcast per episode and each month.

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.

Chart Rankings

How this podcast ranks in the Apple Podcasts, Spotify and YouTube charts.

Apple Podcasts
#10
Russia/Science/Life Sciences
Apple Podcasts
#22
Taiwan/Science/Life Sciences
Apple Podcasts
#34
Switzerland/Science/Life Sciences
Apple Podcasts
#78
Norway/Science/Life Sciences
Apple Podcasts
#101
Finland/Science/Life Sciences
Apple Podcasts
#124
Sweden/Science/Life Sciences
Apple Podcasts
#140
Russia/Science
Apple Podcasts
#145
Taiwan/Science
Apple Podcasts
#161
Austria/Science/Life Sciences
Apple Podcasts
#185
Denmark/Science/Life Sciences

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Audience Metrics

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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 159 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.

View all the reviews in one place instead of visiting each platform individually and use this information to decide if a show is worth pitching or not.

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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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