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MedTech Global Insights

MedTech Global Insights

Auteur(s): Ran Chen
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À propos de cet audio

 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.Copyright 2025 Ran Chen Science Sciences biologiques Économie
Épisodes
  • Beyond the CE Mark: Pure Global's Guide to EUDAMED Data Literacy and Dossier Expertise for the EU Market

    Beyond the CE Mark: Pure Global's Guide to EUDAMED Data Literacy and Dossier Expertise for the EU Market
    Nov 24 2025
    In this episode of MedTech Global Insights, we explore the critical challenges and strategic solutions surrounding the EU's EUDAMED database. We move beyond the basics of compliance to discuss why deep data literacy and expert-level management of your EU technical dossier are essential for maintaining market access and ensuring full traceability. We'll break down how EUDAMED is more than just a submission portal; it's a complex ecosystem that reflects the quality and integrity of your entire regulatory file. We discuss practical strategies for aligning your documentation with EUDAMED's stringent requirements and how technology can prevent costly errors and delays. A real-world pain point: Imagine your company’s innovative device being flagged for a full audit by an EU competent authority due to minor data inconsistencies between your EUDAMED submission and your technical dossier. This single issue could halt sales across Europe and trigger a resource-intensive review process. This episode explains how to avoid this nightmare scenario. In this episode, you'll learn: 1. Why is EUDAMED more than just a database, and what does "data literacy" truly mean in this context? 2. How does your existing EU technical dossier directly impact your success or failure with EUDAMED submissions? 3. What are the most common data traceability gaps that can put your EU market presence at risk? 4. How can AI and automation transform your EUDAMED compliance strategy from a burden into an asset? 5. What critical role does a local EU representative play in managing ongoing EUDAMED obligations? 6. Are you prepared for how EUDAMED will change post-market surveillance and vigilance reporting forever? 7. What are the top three mistakes companies make when preparing their dossiers for EUDAMED? Contact us at info@pureglobal.com or visit https://pureglobal.com/.
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    2 min
  • Unlocking the EU Market: Why Pure Global Advocates for an Authorized Representative with Physical Presence in Germany for MDR/IVDR Success.

    Unlocking the EU Market: Why Pure Global Advocates for an Authorized Representative with Physical Presence in Germany for MDR/IVDR Success.
    Nov 23 2025
    This episode of MedTech Global Insights delves into the critical role of the EU Authorized Representative (AR) under the stringent MDR and IVDR. We explore why the AR is no longer a passive administrative contact but a legally liable partner crucial for your market success. Choosing the right AR is a strategic decision that directly impacts your compliance, risk management, and ability to remain on the European market. We uncover the significant dangers of partnering with 'mailbox' AR services and highlight the non-negotiable value of an AR with a physical EU office, published regulatory capabilities, and a deep understanding of the new regulations. Learn how to identify a true regulatory partner who can protect your business, versus a simple address that could jeopardize your entire European operation. Case Study Highlight: Imagine your innovative medical device is gaining traction in Europe, but a critical compliance inquiry from a national authority goes unanswered by your 'virtual' AR. Suddenly, your market access is frozen, and you're facing a regulatory crisis from thousands of miles away. This episode explores how to avoid this costly and damaging pitfall. Key Takeaways: 1. Why is your EU Authorized Representative now legally liable for your products? 2. What are the hidden dangers of choosing a low-cost, 'mailbox only' AR service? 3. How can you verify if an AR truly has published MDR and IVDR capabilities? 4. Why does a physical office in an EU member state matter for regulatory interactions? 5. What specific questions must you ask a potential AR before signing a contract? 6. How does the AR's role integrate with your post-market surveillance and vigilance reporting? 7. What happens when a national competent authority tries to contact an unresponsive AR? 8. How can a single, qualified AR partner streamline access and ensure compliance across the entire EU market? For more information on navigating global MedTech regulations, contact us at info@pureglobal.com or visit https://pureglobal.com/.
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    2 min
  • Navigating the Global Maze of Telemedicine & RPM: How Pure Global Unlocks Market Access for MedTech Innovators

    Navigating the Global Maze of Telemedicine & RPM: How Pure Global Unlocks Market Access for MedTech Innovators
    Nov 22 2025
    The telemedicine and remote patient monitoring (RPM) revolution is here, promising a new era of accessible and personalized healthcare. But for innovators in this space, global expansion presents a daunting maze of fragmented regulations, data privacy laws, and market entry barriers. This episode of MedTech Global Insights dives deep into the real-world challenges of taking a telemedicine or RPM platform global. We explore the complex regulatory landscapes of key markets like the EU and Brazil, discuss the critical importance of data security and interoperability, and reveal how a strategic, unified approach can turn these obstacles into opportunities. Imagine developing a groundbreaking RPM platform that has proven to reduce hospital readmissions by 30% in the United States. You're ready to expand into Europe and South America, but you're suddenly facing a roadblock. The EU classifies your software as a high-risk medical device under MDR, requiring a costly and time-consuming certification process you weren't prepared for. Meanwhile, Brazil requires a local representative and has entirely different data privacy laws. Your global launch is stalled, and your innovation is trapped by regulatory complexity. What you will learn in this episode: 1. Why is my US-approved telehealth platform not automatically accepted in the EU or Japan? 2. What is "Software as a Medical Device" (SaMD), and how does it impact my regulatory strategy? 3. How can I navigate differing data privacy laws like GDPR and HIPAA without redesigning my product for every market? 4. What are the biggest interoperability challenges when integrating with hospital EHR systems globally? 5. Is it possible to use a single technical dossier to enter multiple countries at once? 6. How do I find a reliable local representative in markets like Brazil or South Korea? 7. What role does AI play in accelerating regulatory submissions for digital health products? 8. How can I stay updated on constantly changing telehealth regulations across more than 30 countries? Contact us at info@pureglobal.com or visit https://pureglobal.com/
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    4 min
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