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PODCAST

MedTech Global Insights

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.

science life sciences

All Episodes

01:50

Europe's EUDAMED Deadline: The Final Countdown | A...

MedTech Global Insights ·

2025/12/19

The European Commission has ended years of uncertainty by announcing a mandatory deadline for EUDAMED. As of May 28, 2026, medical device and IVD companies must comply with the database's core modules. This isn't just a new database; it's a new era of regulatory transparency that demands immediate and strategic action from everyone in the MedTech industry.This episode breaks down what the mandatory deadline for Actor, UDI/Device, and Certificate registration truly means. We explore the massive

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01:43

UK MedTech: Pure Global on GSK's Post-Brexit...

MedTech Global Insights ·

2025/12/18

This week, we unpack the major implications of the UK MHRA's landmark approval of GSK's new twice-yearly asthma treatment. This is more than a product launch; it's a crucial signal for the global MedTech industry on how to successfully navigate the complex and independent post-Brexit regulatory landscape. We explore why the UK is re-emerging as a viable, first-launch market for innovative devices.We analyze the specific regulatory hurdles that trip up many companies, from UKCA marking to divergent

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02:16

Boston's AI Challenge: FDA's New Rules | A Pure...

MedTech Global Insights ·

2025/12/17

Last week, the FDA unveiled a game-changing fast-track for AI diagnostics, but a hidden challenge is already causing chaos for unprepared companies. We break down the new 'Agile PMS' framework and what it means for your market access strategy.This new rule isn't just theory. We explore the real-world case of CardiaAI, a leading Boston-based startup that had its breakthrough product put on hold. Their story reveals the critical resource and data management gaps that this new regulation exposes,

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02:11

Pure Global: USA MedTech's Risky QMS Shift Beyond ISO...

MedTech Global Insights ·

2025/12/16

The US FDA is making its biggest change to quality system regulations in a generation, harmonizing with the global ISO 13485 standard. This shift, mandated by the new Quality Management System Regulation (QMSR), presents both opportunities for streamlined global compliance and significant hidden risks for unprepared manufacturers.Many global companies with existing ISO 13485 certification are operating under the dangerous assumption that they are already compliant. We explore a real-world case

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02:14

Pure Global: Brussels' AI Medical Device Compliance Trap

MedTech Global Insights ·

2025/12/15

The promise of AI in MedTech is undeniable, but a major regulatory storm is brewing in the European Union. A new, complex dual-compliance framework now requires AI-driven medical devices to satisfy both the rigorous Medical Device Regulation (MDR) and the brand-new EU AI Act. This episode of MedTech Global Insights dives deep into what this means for manufacturers, from startups to global enterprises. We explore the immense challenge of navigating two separate sets of demanding requirements

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01:54

Pure Global: US AI MedTech & The FDA's Regulatory Chaos

MedTech Global Insights ·

2025/12/14

The explosion of AI in MedTech is met with a tangled web of new global regulations. This week, we dissect the latest guidance from the IMDRF and explore the growing divide between regulatory bodies in the US, Europe, and beyond. For AI device makers, the path to market is now filled with more hidden risks than ever.We explore the critical case of "CardioClear AI," a company whose groundbreaking diagnostic tool was recalled. Their self-learning algorithm "drifted" outside its approved limits,

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02:26

US DHT Trials: FDA's Hidden Rules | A Pure Global Brief

MedTech Global Insights ·

2025/12/13

In this episode of MedTech Global Insights, we dissect the FDA's newly finalized guidance on using Digital Health Technologies (DHTs) for remote data collection in clinical trials. This pivotal update opens the door for more decentralized and patient-centric studies but introduces stringent new requirements for verification, validation, and data integrity that will reshape how MedTech companies approach clinical research. We explore what the "fit-for-purpose" standard truly means for companies

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02:09

Europe's New Cyber Rules: Pure Global on MedTech's...

MedTech Global Insights ·

2025/12/12

The European Union has rolled out tough new cybersecurity regulations for medical devices, forcing manufacturers to rethink their entire approach to product security. This episode dives into the practical challenges companies are facing, from securing legacy products to meeting intensive new documentation and surveillance demands.We explore the case of a German pacemaker manufacturer struggling to adapt its successful legacy devices to the new rules. Their story highlights the immense technical

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02:13

Brussels' MedTech Labyrinth: Pure Global on the...

MedTech Global Insights ·

2025/12/11

This week, we dive into a major regulatory challenge brewing in the European Union. MedTech Europe has officially called on the European Commission to resolve the long-standing conflict between the Medical Device Regulation (MDR) and the WEEE directive on electronic waste. This move could reshape compliance for any company selling electronic medical devices in the EU.We unpack how this regulatory overlap creates double the work, increases costs, and poses significant market access barriers for

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02:03

Pure Global: US AI Health-Tech and The Denial Algorithm

MedTech Global Insights ·

2025/12/10

The first week of December saw Artificial Intelligence take center stage in MedTech, but not always for the right reasons. While new systems promise to revolutionize patient triage in Greece and reduce physician burnout in the US, a more alarming trend has emerged. Major health insurers are now using AI to automatically deny patient claims, raising serious ethical and regulatory questions.This episode of MedTech Global Insights explores this AI paradox. We contrast the efficiency gains of AI

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02:18

USA Digital Health: Navigating FDA's New...

MedTech Global Insights ·

2025/12/09

Last week, the US FDA's new digital health pilot program sent ripples through the MedTech industry. This is more than a simple regulatory update; it's a pivotal shift that moves cybersecurity from a compliance task to a major commercial and contractual battleground, fundamentally changing the rules for market access. This episode breaks down how the convergence of new FDA initiatives and proactive industry standards is creating unforeseen hurdles. The burden of proof for cybersecurity has

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01:55

Brazil's MedTech Maze: Pure Global's AI Escape from...

MedTech Global Insights ·

2025/12/08

Traditional MedTech global expansion is broken, defined by premium consulting fees, opaque processes, and frustrating delays. This episode of MedTech Global Insights unpacks the new playbook for international market access, revealing how companies are finally breaking free from the old model. We explore how the strategic fusion of advanced AI and on-the-ground regulatory experts is revolutionizing the industry. Discover how Pure Global's proven approach helps companies slash timelines, reduce

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02:17

Germany to FDA: Pure Global's AI Crushes Doc Bottlenecks

MedTech Global Insights ·

2025/12/07

In this episode of MedTech Global Insights, we tackle the silent killer of speed-to-market: regulatory documentation bottlenecks. As companies expand globally, the sheer volume and complexity of preparing submissions for different health authorities can lead to costly delays and divert expert teams to low-value administrative work.We explore how cutting-edge AI is transforming this landscape. Discover how AI agents automate everything from device classification to technical file generation and

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01:56

Pure Global: Brazil's MedTech AI & Decoding...

MedTech Global Insights ·

2025/12/06

In the fast-paced world of MedTech, falling behind on regulatory changes isn't just a risk; it's a guarantee of costly delays and missed opportunities. The sheer volume of updates from global health authorities has made manual tracking an impossible task, leaving even the most diligent teams vulnerable to compliance gaps. This episode of MedTech Global Insights dives into the AI revolution in regulatory affairs. We explore how Pure Global's real-time intelligence platform transforms the chaotic

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01:55

Pure Global: Brazil MedTech AI - Unlocking 75% Faster...

MedTech Global Insights ·

2025/12/05

Are you ready to accelerate your MedTech or IVD product's global launch by 75%? In this episode of MedTech Global Insights, we explore how Pure Global's advanced AI platform is dismantling the traditional barriers to international market access, transforming a multi-year ordeal into a matter of months.We dive into how this technology provides real-time regulatory intelligence and automated compliance pathways, achieving a 95% approval success rate across 30+ major markets, including the FDA, EU,

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02:22

EU MedTech's Unfair Advantage: Pure Global's...

MedTech Global Insights ·

2025/12/04

In an industry where regulatory costs and complexities can stifle innovation, Pure Global's AI platform emerges as a game-changer. This episode of MedTech Global Insights delves into the five strategic advantages of leveraging their free, powerful AI agents to navigate the intricate world of global medical device registration. We explore how this technology isn't just an incremental improvement but a fundamental disruption to the old models of market access.We uncover how companies can drastically

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02:13

Cracking the Code of Global MedTech Expansion: How...

MedTech Global Insights ·

2025/12/03

In this episode of MedTech Global Insights, we explore the number one hurdle for ambitious medical device and IVD companies: navigating the fragmented and complex world of international regulations. We unpack why the traditional, country-by-country approach to market entry is inefficient and costly in today's fast-paced environment.We then break down a modern, integrated strategy for global expansion. This involves leveraging a core technical dossier across multiple markets simultaneously, powered

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02:26

Unlocking MedTech Success in China: Why a...

MedTech Global Insights ·

2025/12/02

In this episode of MedTech Global Insights, we explore the paradigm shift in global market access strategy. We move beyond the traditional, fragmented approach of managing regulatory hurdles country by country and dive into the rise of integrated, technology-driven consulting firms. These firms are not just advisors; they are end-to-end partners with a clear mission to streamline global expansion. We discuss how leveraging a single, centralized process combined with in-country expertise and

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02:25

Unlocking APAC MedTech Markets: How Pure Global...

MedTech Global Insights ·

2025/12/01

Navigating the complex, ever-changing web of global MedTech regulations is a primary barrier to market entry. The traditional, manual approach is notoriously slow, costly, and fraught with risks of rejection, delaying access to critical innovations for patients worldwide. This episode of MedTech Global Insights explores a new, technology-driven paradigm. We dive into how embedding advanced AI and a massive global database directly into regulatory services is transforming the industry. Learn how

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02:09

From Chaos to Clarity: Navigating MedTech Regulations...

MedTech Global Insights ·

2025/11/30

The global MedTech regulatory landscape is a maze of constantly changing rules and fragmented information. Relying on static guides or old webinars leads to costly delays and rejected submissions. This episode explores a modern solution: a "living library" of expert global insights that converts complex knowledge into simple, actionable checklists for your specific products and target markets.We break down how this dynamic approach transforms your regulatory strategy from reactive to proactive

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