MedTech Global Insights Podcast Por Ran Chen arte de portada

MedTech Global Insights

MedTech Global Insights

De: Ran Chen
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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 Ciencia Ciencias Biológicas Economía
Episodios
  • Boston's AI Challenge: FDA's New Rules | A Pure Global Takedown

    Boston's AI Challenge: FDA's New Rules | A Pure Global Takedown
    Dec 17 2025
    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, serving as a warning for the entire industry. This week's insights: - What exactly is the FDA's 'Agile PMS' and is your current system compliant? - Why did the new fast-track pathway immediately become a roadblock for a top startup? - What are the three critical data infrastructure changes you need to make right now? - How can you leverage existing technical dossiers for the new PMS requirements without starting from scratch? - Is it possible to automate the new real-time reporting demands? - What are the hidden costs associated with this new compliance framework? Contact us at info@pureglobal.com or visit https://pureglobal.com/ or visit https://pureglobal.ai/ for FREE AI tools and a free medical device database.
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    2 m
  • Pure Global: USA MedTech's Risky QMS Shift Beyond ISO 13485

    Pure Global: USA MedTech's Risky QMS Shift Beyond ISO 13485
    Dec 16 2025
    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 where a European company, despite being fully CE-marked, discovered critical gaps in their risk management and supplier controls that would have resulted in serious FDA non-compliance, jeopardizing their US market access. This episode breaks down the specific differences and what you need to do now. Key Takeaways: - Why is the FDA's new QMSR more than just a copy-paste of ISO 13485? - What are the top three "hidden gaps" between your current ISO certificate and full FDA compliance? - How does the new rule fundamentally change the approach to risk management for devices sold in the US? - What specific records and procedures will FDA inspectors scrutinize most under the new QMSR? - Is your management review process truly ready for the new, stricter requirements? - How can you leverage this transition to streamline your global quality strategy instead of just adding paperwork? - What are the critical FDA "carve-outs" in the final rule that most consultants are not talking about? Contact us at info@pureglobal.com or visit https://pureglobal.com/ or visit https://pureglobal.ai/ for FREE AI tools and free medical device database.
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    2 m
  • Pure Global: Brussels' AI Medical Device Compliance Trap

    Pure Global: Brussels' AI Medical Device Compliance Trap
    Dec 15 2025
    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. Consider a company with a market-ready AI diagnostic tool, holding a complete MDR technical file. They suddenly find their product classified as "high-risk" under the AI Act, forcing them into a costly and time-consuming redesign of their entire compliance, data governance, and risk management strategy, putting their European launch in jeopardy. What You'll Learn: - Why is the EU's new AI Act creating a dual compliance headache for MedTech innovators? - What does it mean to navigate both the MDR and the AI Act simultaneously? - How does the AI Act's "high-risk" classification impact your regulatory strategy? - Is your current Quality Management System prepared for AI-specific demands? - What are the new rules for post-market surveillance of AI algorithms? - Why are cross-functional teams of engineers and regulatory experts now essential? - What critical questions must you ask about your AI's training data to ensure compliance? - How can you avoid common pitfalls that lead to costly market launch delays? Contact us at info@pureglobal.com or visit https://pureglobal.com/. Explore our FREE AI tools and medical device database at https://pureglobal.ai/.
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    2 m
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