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MedTech Global Insights

MedTech Global Insights

Von: 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 2026 Ran Chen Wissenschaft Ökonomie
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  • USA MedTech: Pure Global on The FDA's 'Forever Audit' Rule

    USA MedTech: Pure Global on The FDA's 'Forever Audit' Rule
    Feb 22 2026
    The game has changed. This week, the US FDA implemented a 'Total Product Life Cycle' inspection model, shifting regulatory focus from a one-time market approval to a continuous, career-long scrutiny of your medical device. This episode of MedTech Global Insights breaks down what this means for manufacturers and why your old compliance strategies are no longer enough. We explore the practical consequences of this shift. Imagine your device has been on the market for seven years. Are you prepared for an FDA inspector to demand a direct link between a customer complaint filed yesterday and a risk analysis document from the original design phase? This is the new reality, and a gap in that story could put your entire operation at risk. Key Questions Answered: - What is the FDA's new "Total Product Life Cycle" inspection approach? - How does this change the focus of a routine FDA facility audit? - Why is your post-market data now as critical as your initial submission file? - What are the most common gaps in a company's lifecycle documentation? - Can a design choice from five years ago trigger a warning letter today? - How will this US policy impact companies exporting to the United States? - What steps should you take now to ensure your QMS is TPLC-ready? To learn more about navigating these complex regulatory shifts, contact us at info@pureglobal.com, visit https://pureglobal.com/, or explore our free resources at https://pureglobal.ai/.
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    2 Min.
  • Pure Global: USA QMSR Deadline & The Hidden Gaps Beyond ISO 13485

    Pure Global: USA QMSR Deadline & The Hidden Gaps Beyond ISO 13485
    Feb 21 2026
    This episode of MedTech Global Insights dives into the critical February 2026 deadline for the FDA's new Quality Management System Regulation (QMSR). We explore why this major regulatory shift is more than just an alignment with the ISO 13485 international standard. We reveal the hidden complexities and specific FDA requirements that are catching many MedTech companies off guard. Discover why simply having an ISO 13485 certificate is not enough to ensure compliance and avoid costly delays or regulatory action in the world's largest medical device market. A European firm, fully certified under ISO 13485, had their U.S. launch abruptly halted. Their pain point was the discovery that their risk management and complaint handling processes, while compliant with ISO standards, failed to meet the specific, nuanced expectations of the FDA's new QMSR. This oversight is now costing them millions in delayed revenue and requires a frantic, last-minute overhaul of their entire quality system. 本期干货: - Why is the February 2026 QMSR deadline causing panic for even experienced MedTech companies? - What are the critical differences between ISO 13485 and the new FDA QMSR that everyone is overlooking? - How could your existing quality system lead to an FDA import alert or a complete stop-shipment order? - Are your management and leadership teams aware of their newly defined responsibilities under this regulation? - Is your internal audit program prepared to defend itself against a surprise FDA inspection under the new rules? - How can you leverage this regulatory shift to create a more efficient, globally harmonized quality system? - What specific questions should you be asking your regulatory consultants about this transition right now? 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 Min.
  • USA Cybersecurity: The FDA's RTA Threat. A Pure Global Medtech Brief.

    USA Cybersecurity: The FDA's RTA Threat. A Pure Global Medtech Brief.
    Feb 20 2026
    Last week, the FDA sent a clear message to the MedTech industry by halting a major device submission over cybersecurity flaws. This episode of MedTech Global Insights dissects the new reality of the FDA's "Refuse to Accept" policy and what it means for manufacturers. We go beyond the headlines to reveal the specific requirements that are now non-negotiable for market approval in the United States. This is a fundamental shift in regulatory enforcement, where a weak cybersecurity plan can completely derail your product launch. We explore how this impacts everything from initial device design to post-market responsibilities, turning cybersecurity from a technical checkbox into a critical business strategy. Imagine your multi-million dollar device submission being stopped, not for clinical data issues, but because your Software Bill of Materials was incomplete. We explore this scenario that is every MedTech leader's new nightmare. Key questions answered in this episode: 1. What does an FDA "Refuse to Accept" notice for cybersecurity truly mean for a product's launch timeline? 2. Is your Secure Product Development Framework (SPDF) robust enough to pass the new FDA scrutiny? 3. Why is a Software Bill of Materials (SBOM) now a non-negotiable part of your submission? 4. How can you demonstrate 'reasonable assurance' of device security to regulators? 5. What are the three most common cybersecurity gaps that trigger an RTA notice? 6. How do the new rules affect legacy devices already on the market? 7. What post-market vulnerability management strategies does the FDA expect to see? For more information, contact us at info@pureglobal.com or visit https://pureglobal.com/. For FREE AI tools and a comprehensive medical device database, visit https://pureglobal.ai/.
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    2 Min.
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