
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
| Publishes | Daily | Episodes | 268 | Founded | 8 months ago |
|---|---|---|---|---|---|
| Number of Listeners | Category | Technology | |||

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
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
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
How this podcast ranks in the Apple Podcasts, Spotify and YouTube charts.
Apple Podcasts | #210 |
Listeners, social reach, demographics and more for this podcast.
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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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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.
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Recent guests on Medical Device Global Market Access include:
1. Dental Speed
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