Episodes

  • 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 mins
  • 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 mins
  • 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 mins
  • Pure Global: USA MedTech Cybersecurity & Its Hidden Deal Killers

    Pure Global: USA MedTech Cybersecurity & Its Hidden Deal Killers
    Feb 19 2026
    The FDA's new cybersecurity rules are more than just a regulatory checklist; they're reshaping the landscape for MedTech investment and acquisitions. Many innovative startups are discovering that their market access and company valuation now hinge entirely on their cybersecurity preparedness, an area they may have overlooked. This episode of MedTech Global Insights explores the immediate business impact of these stringent new requirements. We uncover why a lack of cybersecurity documentation is becoming a common reason for the FDA to reject new device submissions and, more critically, why it's becoming a deal-breaker in high-stakes M&A negotiations. A fast-growing startup with a breakthrough cardiac monitoring device was in the final stages of a major acquisition. The deal collapsed unexpectedly. The reason was not the device's clinical performance, but its failure to produce a complete Software Bill of Materials (SBOM) as required by the new FDA cybersecurity guidance. The acquiring company's due diligence team flagged it as a critical liability, making the deal too risky to proceed. 本期干货: - What are the three non-negotiable items the FDA now demands in every cybersecurity submission? - Why is an incomplete Software Bill of Materials (SBOM) becoming a primary red flag for investors? - How can early-stage startups implement a compliant Secure Product Development Framework without a large budget? - What specific documentation are acquiring companies demanding during M&A due diligence? - How do the new US cybersecurity rules affect devices that are also seeking CE marking in Europe? - Is your current regulatory strategy robust enough to pass both an FDA review and a buyer's scrutiny? - What are the hidden costs of remediating a device that was not designed with cybersecurity in mind from day one? For more insights, contact us at info@pureglobal.com or visit https://pureglobal.com/. For free AI tools and a comprehensive medical device database, check out https://pureglobal.ai/.
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    2 mins
  • USA's AI MedTech: Pure Global on The New FDA Algorithm Trap

    USA's AI MedTech: Pure Global on The New FDA Algorithm Trap
    Feb 18 2026
    This week, we dissect the FDA's groundbreaking new draft guidance on AI/ML-enabled medical devices. This isn't just another regulation. it's a paradigm shift that redefines the rules for software as a medical device. We explore how the requirement for a "Predetermined Change Control Plan" (PCCP) is creating significant new hurdles for innovators in the MedTech space. We break down what this means for manufacturers, from startups to enterprise leaders. For instance, a company with a brilliant, continuously learning algorithm for early cancer detection now faces a critical challenge: how to innovate at speed while adhering to a rigid framework that demands every significant update be pre-planned and validated. This episode provides the insights you need to navigate this new reality. What You'll Learn: - What exactly is the FDA's new guidance for AI devices, and why does it demand your immediate attention? - How does a "Predetermined Change Control Plan" work, and what are the hidden complexities? - Could your self-improving algorithm become your biggest regulatory liability? - Why do continuous learning models face the most significant challenges under these new rules? - How will this U.S. policy shift impact your global market access strategy, including CE marking in Europe? - What are the essential documentation and risk management strategies you must implement now? - Is this new regulatory friction signaling a slowdown for rapid innovation in AI MedTech? For more information, contact us at info@pureglobal.com, visit https://pureglobal.com/, or access our FREE AI tools and medical device database at https://pureglobal.ai/.
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    2 mins
  • USA's AI Diagnostics: Pure Global on FDA's Hidden Cyber Traps

    USA's AI Diagnostics: Pure Global on FDA's Hidden Cyber Traps
    Feb 17 2026
    This week on MedTech Global Insights, we dissect the FDA's surprising new focus on AI-powered medical devices. A recent public enforcement action has sent a clear message: pre-market approval is no longer enough. The agency is now intensely scrutinizing the hidden risks of post-market cybersecurity and algorithm performance. We break down what this regulatory shift means for MedTech innovators worldwide. From the challenge of 'data drift' to the unseen vulnerabilities in routine software updates, we explore the new compliance traps that can derail even the most promising technologies after they have launched successfully. **Case Study:** Imagine your revolutionary AI diagnostic tool, already approved and used by hospitals, is suddenly flagged by regulators for a cybersecurity flaw in its connection to a hospital's network. This isn't a hypothetical; it's the new reality companies are facing. We discuss how to prepare for this before it becomes a crisis. **What You'll Learn:** - Why is the FDA shifting its focus from pre-market approval to post-market vigilance for AI devices? - What is 'algorithm drift' and why is it now a top regulatory concern? - How can a seemingly minor software update trigger a full regulatory review? - What are the essential cybersecurity documents you must have ready for auditors at all times? - Are your current post-market surveillance plans adequate for AI-driven software? - How do you prove your device is secure when connected to third-party hospital systems? - What lessons can we learn from the EU's parallel approach to AI regulation? - Is your technical dossier prepared for this new, continuous level of scrutiny? 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 mins
  • Boston's Neurovascular Gambit: Pure Global on M&A Chaos

    Boston's Neurovascular Gambit: Pure Global on M&A Chaos
    Feb 16 2026
    In this episode, we dissect the massive acquisition of Penumbra by Boston Scientific. We go beyond the financial headlines to explore the immense, unseen regulatory and logistical challenges that lie ahead as these two MedTech giants merge their global operations. This is not just a story of market consolidation; it is a case study in navigating the treacherous waters of international compliance. The real challenge begins now: How does Boston Scientific integrate Penumbra's product portfolio across more than 30 international markets without disrupting sales or violating local regulations? We look at the specific hurdles they will face in the European Union, China, and other key regions, where a single misstep in transferring technical files or updating local representation could halt business for months. Key Takeaways: - Why did a cardiology leader pivot to acquire a neurovascular specialist? - What are the critical differences in regulatory integration for the EU versus China? - How do you manage the transfer of thousands of technical dossiers without costly errors? - Could this merger actually delay new product launches in emerging markets? - What happens to existing distribution contracts and local representatives post-acquisition? - How will they consolidate two separate post-market surveillance systems? - What are the hidden risks in aligning two different Quality Management Systems? 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 mins
  • Brussels' IVDR Reprieve: Pure Global on Navigating the Chaos

    Brussels' IVDR Reprieve: Pure Global on Navigating the Chaos
    Feb 15 2026
    The European Commission has just proposed another extension to the challenging IVDR transition deadlines, granting diagnostic manufacturers critical breathing room. In this episode, we break down what these new dates mean and analyze the systemic crisis that made this delay necessary. This is not a simple postponement. it's a reaction to the severe shortage of Notified Bodies and the real risk of essential medical tests vanishing from the European market. We explore the strategic decisions that companies must now make to leverage this extra time effectively, warning against the critical dangers of complacency. A real-world pain point: Imagine you're a US-based scaleup with a successful diagnostic test approved under the old IVDD directive. Your EU sales are critical, but you've been stuck in a Notified Body queue for 18 months with the original compliance deadline looming. This news gives you breathing room, but do you double down on the costly IVDR process or use this window to accelerate expansion into less complex markets? The clock is still ticking. Key Takeaways for this episode: 1. What are the specific new proposed deadlines for Class D, C, and B IVDs? 2. Why was this IVDR extension absolutely necessary to prevent a public health crisis? 3. What are the top three mistakes a manufacturer could make after hearing this news? 4. How does this delay impact Notified Body capacity and their audit schedules? 5. Should you change your global registration strategy because of the EU's delay? 6. What specific technical file remediation should be your top priority right now? 7. Could this extension truly be the final one from the European Commission? For more information, contact us at info@pureglobal.com or visit https://pureglobal.com/. You can also visit https://pureglobal.ai/ for FREE AI tools and a free medical device database.
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    2 mins