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Artwork for Medical Device Global Market Access

Medical Device Global Market Access

Pure Global
Medical Devices
Real-World Data
EU MDR
EU In Vitro Diagnostic Regulation
Software As a Medical Device
CE Marking
Clinical Trials
ISO 13485
Supply Chain Controls
ISO 13485-2016
FDA 2024 QMSR
European Union
Medical Device Regulation
FDA
Anvisa
MHRA Guidelines
In Vitro Diagnostic Devices Regulation
Udamed Database
Unique Device Identifier
Saudi Food and Drug Authority

Navigate every market. Accelerate every launch. Medical Device Global Market Access by Pure Global is the audio briefing that turns the world’s most confusing regulatory pathways into clear, actionable roadmaps. If you’re a MedTech founder, RA/QA leader, product manager, or investor who needs to get devices cleared anywhere from Austin to Abu Dhabi, this show is your shortcut. Why listen? • Step-b... more

PublishesDailyEpisodes268Founded8 months ago
Number of ListenersCategory
Technology

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Artwork for Medical Device Global Market Access

Latest Episodes

This episode explores the critical shift in regulatory focus from Post-Market Surveillance (PMS) planning to execution. We discuss why Notified Bodies and regulators, particularly under the EU MDR, are no longer accepting PMS and Post-Market Clinical... more

This episode delves into the stringent clinical evidence requirements under the European Union's Medical Device Regulation (MDR 2017/745). We explore the top challenges manufacturers face, including the heightened standards for clinical evaluation pl... more

YouTube

This episode delves into the ongoing Notified Body capacity crisis for EU MDR and IVDR certification. Despite extended transition deadlines, significant bottlenecks in audit scheduling and technical documentation review are creating a "timeline compr... more

YouTube

This episode unpacks the European Commission's significant proposal of December 16, 2025, aimed at the targeted simplification of the MDR and IVDR. We explore the potential impacts on documentation, digitalization through EUDAMED, and what these chan... more

YouTube

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Dental Speed
A prominent distributor in Brazil's dental space established in 1996, supplying products directly to dental practices and laboratories.
Dental Speed
Episode: Brazil's Dental Market: Unlocking Access with Key Distributors like Dental Speed

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Pure Global
Host of Medical Device Global Market Access.

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Apple Podcasts
#210
Taiwan/Technology

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Frequently Asked Questions About Medical Device Global Market Access

What is Medical Device Global Market Access about and what kind of topics does it cover?

The content revolves around guiding MedTech professionals through the complex landscape of medical device regulations across various countries. Episodes aim to provide actionable insights and strategies for navigating regulatory processes in regions like the United States, Europe, and Brazil, among others. Key themes include practical tips for regulatory submissions, firsthand experiences from industry veterans, and real-time updates on changing guidelines and trends. The podcast uniquely emphasizes the integration of artificial intelligence to streamline regulatory navigation, presenting data-driven strategies to help listeners efficiently bring medical devices to market.

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How many listeners does Medical Device Global Market Access get?

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What are the audience demographics for Medical Device Global Market Access?

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How many subscribers and views does Medical Device Global Market Access have?

To see how many followers or subscribers Medical Device Global Market Access 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.

Which podcasts are similar to Medical Device Global Market Access?

These podcasts share a similar audience with Medical Device Global Market Access:

1. Asia Business Podcast

How many episodes of Medical Device Global Market Access are there?

Medical Device Global Market Access launched 8 months ago and published 268 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 Medical Device Global Market Access?

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Where can I see ratings and reviews for Medical Device Global Market Access?

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What guests have appeared on Medical Device Global Market Access?

Recent guests on Medical Device Global Market Access include:

1. Dental Speed

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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