Medical Device Global Market Access
Pure GlobalNavigate 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 | 377 | Founded | a year ago |
|---|---|---|---|---|---|
| Number of Listeners | Category | Technology | |||
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Latest Episodes
This episode covers the recent closure of Brazil ANVISA's public consultation (Call for Contributions No. 4/2026) on a new technovigilance framework. We discuss the implications for medical device manufacturers, the expected changes to adverse event ... more
This episode details the significant amendments to South Korea's Medical Device Act, effective July 1, 2026. We cover the two key changes from the Ministry of Food and Drug Safety (MFDS): the formalization of the Quality Management System (QMS) Confo... more
The Saudi Food and Drug Authority (SFDA) published a new guidance, MDS-G-029, on July 9, 2026, establishing formal requirements for medical device risk communication. This episode breaks down the key principles of the guidance, including the responsi... more
Health Canada has introduced a new Ministerial Reliance Order, effective July 15, 2026, designed to accelerate market access for medical devices and drugs. This episode breaks down how the new reliance pathway allows manufacturers to leverage approva... more
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Apple Podcasts | #234 |  United Kingdom/Technology |
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| Listeners per Episode | Gender Skew | Location | |||
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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 show concentrates on navigating global regulatory and market-access pathways for medtech products, with a strong emphasis on end-to-end strategies across regions. Across episodes, listeners hear practical roadmaps for launching software-as-a-medical-device and hardware devices, handling EU MDR and 510(k) processes, country-specific registrations, and post-market considerations such as cybersecurity and real-world evidence. A recurring theme is aligning regulatory strategy with business goals—often framed as “reg-first” approaches—and translating complex compliance requirements into actionable playbooks, templates, and risk-based decision making. Notable strengths include data-backed guidance drawn from global filings and recalls, candid... more
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How many subscribers and views does Medical Device Global Market Access have?
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How many episodes of Medical Device Global Market Access are there?
Medical Device Global Market Access launched a year ago and published 377 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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What guests have appeared on Medical Device Global Market Access?
Recent guests on Medical Device Global Market Access include:
1. Dental Speed
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