MedTech Global Insights

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/.

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.

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/.

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/.

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/.

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.

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/.

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.

This week, MedTech Global Insights dives into the historic shift in FDA regulation that took effect on February 2, 2026. The new Quality Management System Regulation (QMSR) aligns U.S. standards with the global ISO 13485 benchmark, fundamentally altering the landscape for every medical device manufacturer operating in the United States. We break down the most critical change: the new level of transparency required during FDA audits. Previously shielded internal documents, including candid management review minutes, are now open to inspectors. This shift demands a profound cultural change towards proactive risk management and a defensible, top-down quality culture. Pain Point Example: Imagine your executive team's confidential discussion about a supplier risk is now the first thing an FDA inspector wants to see. A single undocumented decision in those meeting minutes could trigger a cascade of regulatory actions. Are you prepared for this new reality? Key Takeaways: 1. What specific internal records are now accessible to FDA inspectors under QMSR?. 2. How does the new rule redefine the role and liability of executive management in quality oversight?. 3. What are the top three differences between the old QSR and the new QMSR that you must address immediately?. 4. How can aligning with ISO 13485 actually accelerate your entry into other global markets?. 5. What is the first step your company should take to prepare for a surprise FDA audit under these new rules?. 6. Does this harmonization make it easier or harder for international companies to enter the U.S. market?. 7. How do you document a 'culture of quality' in a way that satisfies an auditor?. Contact us at info@pureglobal.com or visit https://pureglobal.com/. Explore our FREE AI tools and medical device database at https://pureglobal.ai/.

In a landmark decision, the U.S. FDA has finalized its rule to regulate Laboratory Developed Tests (LDTs) as medical devices, ending decades of enforcement discretion. This episode of MedTech Global Insights unpacks the immediate and long-term consequences of this industry-altering shift. We explore why the FDA made this move, what it means for clinical labs, and how it redraws the competitive map for diagnostic innovators. This isn't just a policy update; it's a fundamental change that will create new winners and losers across the MedTech landscape. We examine the tough road ahead for academic medical centers and startups, who now face the same stringent requirements as large commercial manufacturers. For patients and providers, this change promises safer, more reliable diagnostics, but at what potential cost to innovation and access to tests for rare conditions? **Key Takeaways:** * Why did the FDA end its decades-long hands-off approach to LDTs now? * What specific pre-market and post-market requirements will labs now face? * How will this regulatory shift impact patient access to cutting-edge diagnostics? * Which types of companies stand to win or lose in this new regulatory environment? * Could this rule stifle or ultimately improve the pace of diagnostic innovation? * What are the key deadlines in the FDA's multi-year phase-in plan? * How does this U.S. policy change affect international companies trying to enter the market? For more insights, contact us at info@pureglobal.com, visit https://pureglobal.com/, or access our FREE AI tools and medical device database at https://pureglobal.ai/.

A recent cybersecurity breach at a major US hospital, targeting connected infusion pumps, has sent shockwaves through the MedTech industry. The incident, which triggered a joint alert from the FDA and CISA, highlights the critical vulnerabilities that exist even in trusted medical devices and the immense pressure now on manufacturers. This episode of MedTech Global Insights unpacks the event and explores the new reality of cybersecurity compliance. We discuss the stringent new requirements from the FDA, including the mandatory Software Bill of Materials (SBOM), and how they align with the EU's MDR, forcing a complete lifecycle approach to device security. Imagine this scenario. a successful scaleup company finds its flagship diagnostic device, installed in hundreds of clinics, is suddenly vulnerable. A flaw was discovered not in their code, but in an open-source library their developers used years ago. Now, they face a regulatory nightmare, with market access at risk because they cannot prove to regulators they have a process to manage third-party software risks effectively. 本期干货: - Why is the latest US hospital breach a critical wake-up call for all IVD and MedTech firms globally? - What does the FDA's mandatory Software Bill of Materials (SBOM) *really* mean for your development team? - How do the EU MDR and FDA's cybersecurity guidances overlap, and where are the critical differences? - What are the most overlooked vulnerabilities hiding in legacy medical devices? - Is your post-market surveillance plan truly prepared for a zero-day exploit in third-party code? - How can you turn the burden of cybersecurity compliance into a competitive advantage and a mark of quality? - What crucial questions should you be asking your software suppliers and internal teams 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.

The U.S. FDA has finalized its rule to regulate Laboratory Developed Tests (LDTs) as medical devices, ending a long-standing policy of enforcement discretion. This episode of MedTech Global Insights breaks down one of the most significant regulatory shifts in the diagnostics industry in decades. We explore the immediate, practical consequences for clinical laboratories, from new compliance burdens to critical strategic decisions. We move beyond the headlines to examine what this means on the ground. For example, how does a university lab that developed a critical test for a rare pediatric cancer now cope with the prospect of a multi-million dollar FDA submission process? This rule is forcing labs to make tough choices that will directly impact patient access to innovative diagnostics. What You'll Learn: - Why is the FDA making this change after decades of a hands-off approach? - What are the key differences between former CLIA oversight and new medical device regulations? - How will the requirement for formal Quality Management Systems impact lab operations? - Could this rule create a gap in testing for rare diseases? - What are the first steps a lab should take to build a transition plan? - How might this regulatory shift trigger a new wave of mergers and acquisitions in the diagnostics space? - What are the potential pathways, like 510(k) or De Novo, for existing LDTs to gain approval? - Are there any exemptions for academic medical centers or low-volume tests? 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.

This episode of MedTech Global Insights dives into the increasingly fragmented world of AI medical device regulation. As innovative technologies surge, global markets are responding with unique, localized rules, creating complex challenges for manufacturers. We explore the latest developments and what they mean for your global strategy. We spotlight a critical new case: Hong Kong's recently released guidance on AI medical devices. For a company with an FDA-approved diagnostic tool, this new framework isn't just another piece of paper; it's a potential market barrier requiring a completely new submission strategy, different clinical data, and stricter cybersecurity protocols, ultimately delaying patient access and increasing costs. Key Questions Answered (本期干货): - What does Hong Kong's new AI guidance mean for global MedTech companies? - How do AI regulations differ between Asia, the EU, and the USA? - Why can the same AI device have different risk classifications in different countries? - What are the biggest "hidden" compliance traps when launching an AI medical device globally? - How can you prepare your technical dossier for multiple, divergent regulatory submissions? - What are the key questions regulators are asking about adaptive "learning" algorithms? - How do you build a regulatory strategy that anticipates future changes in AI rules? 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.

This week, the US FDA overhauled its inspection strategy, introducing a "Total Product Life Cycle" (TPLC) approach. This episode of MedTech Global Insights breaks down what this seismic shift means for medical device manufacturers. We move beyond the headlines to explain how the FDA is breaking down traditional compliance silos, demanding a single, unified view of a product from conception to obsolescence. We explore the practical challenges this creates for companies with fragmented data systems and a reactive approach to quality. This isn't just another regulation; it's a new philosophy of continuous accountability that will redefine what it means to be "inspection-ready." A mid-sized diagnostics company recently faced a TPLC-focused inspection. They had strong pre-market data and a decent complaint handling system. However, they were cited because their post-market surveillance data on component failures was not actively informing the design specifications for their next-generation device. The FDA saw this as a critical break in the product lifecycle loop, costing them time and money in remediation. 本期干货: What is the Total Product Life Cycle (TPLC) approach and why is the FDA implementing it now? How does TPLC change the focus of an FDA inspection away from siloed checks? What are the biggest data management challenges companies will face under this new model? Why is a "living" risk management file more critical than ever? How can you prove to an inspector that your post-market data informs your R&D process? What kind of quality management system is required to support a TPLC framework? How does this US-based change impact your strategy for global market access? Are legacy products exempt, or do they also need a TPLC-compliant data trail? 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

In a landmark decision, the US FDA has finalized its rule to replace the decades-old Quality System Regulation with the new Quality Management System Regulation (QMSR). This historic move aligns US medical device standards with the international ISO 13485, marking a significant step towards global harmonization. But this is not a simple copy-and-paste of the global standard. This episode breaks down the critical details of this regulatory shift. We explore why being ISO 13485 certified is not enough to guarantee compliance. We uncover the specific US requirements the FDA has retained, creating a unique hybrid model that manufacturers worldwide must now navigate before the February 2026 deadline. A prime example is a mid-sized American device maker, fully compliant with the old FDA system. They now face a two-year deadline to completely restructure their quality management system, retrain their entire staff, and renegotiate supplier agreements to meet the new risk-centric approach. This is not just new paperwork; it is a fundamental culture shift where one mistake could halt all US sales. Key Takeaways: - The FDA's QMSR is more than just ISO 13485; what key US-specific requirements remain? - If your company is already ISO 13485 certified, are you automatically compliant? - What are the top three priorities for your gap analysis before the 2026 deadline? - How will this change affect your relationships with suppliers and contract manufacturers? - What specific record-keeping practices need to be updated to align with the new rule? - How is the FDA's inspection process expected to change under the new QMSR? - What are the hidden risks of ignoring the subtle differences between the old and new systems? To learn more or for a free consultation, contact us at info@pureglobal.com, visit https://pureglobal.com/, or access our FREE AI tools and medical device database at https://pureglobal.ai/.

The U.S. FDA has just upended the diagnostics world. After decades of operating in a regulatory gray area, laboratory-developed tests (LDTs) will now be regulated as medical devices. This episode of MedTech Global Insights dives deep into what this massive policy shift means for labs, patients, and the entire MedTech industry. We explore the end of the FDA's "enforcement discretion" policy and the beginning of a new era of compliance. We unpack the immense operational and financial challenges facing academic medical centers and specialized labs, who must now navigate the same stringent requirements as major IVD manufacturers. A Real-World Dilemma: Imagine a university lab that developed a groundbreaking genomic test for a rare pediatric cancer. Now, they are considered a medical device manufacturer by the FDA, facing a multi-million dollar compliance burden without the staff or budget. Will their vital test disappear, leaving patients with no options? This is the reality many labs now face. Key Takeaways From This Episode: - Why did the FDA decide to regulate LDTs as devices after decades? - What is the four-year transition timeline, and what are the key compliance deadlines? - How will pre-market review requirements impact innovation in personalized medicine? - What are the strategic options for labs: build, partner, or discontinue tests? - Will this new rule create more opportunities for large IVD companies? - How can labs with limited resources begin building a compliant Quality Management System? - What happens to niche tests for rare diseases that may not be commercially viable under this new rule? For more information, contact us at info@pureglobal.com or visit https://pureglobal.com/. You can also explore our FREE AI tools and medical device database at https://pureglobal.ai/.

This week, we dissect the FDA's sudden and impactful new guidance on Real-World Evidence (RWE) that just sent ripples through the US digital health sector. This isn't just another update; it's a fundamental shift in how data from wearables and EHRs will be scrutinized, potentially derailing existing regulatory strategies for countless SaMD and AI-driven medical devices. We explore the new, stricter demands for data integrity and what it means for companies that have banked their futures on the promise of RWE. We break down the strategic pivots innovators must now consider to stay compliant and competitive, transforming a potential regulatory crisis into a strategic advantage. **Case Study:** A leading digital health firm has spent two years and millions of dollars building a product roadmap based on leveraging real-world data for rapid market expansion. Last week, the new FDA guidance rendered their entire evidence portfolio questionable, putting their next funding round and product launches in jeopardy. Their data asset has suddenly become a massive liability. **What You'll Learn:** 1. What are the critical new data integrity rules in the FDA's RWE guidance? 2. Is your current Real-World Evidence strategy now obsolete? 3. Why did a past failure of a cardiac monitoring app trigger this FDA crackdown? 4. What specific validation steps are now required for data from wearables? 5. How does this shift impact the valuation of digital health startups? 6. What is the new cost of bringing an RWE-supported device to market? 7. How can you turn this regulatory hurdle into a competitive advantage? 8. Will the EU and other markets follow the FDA's lead? For a deeper dive into crafting a resilient global regulatory strategy, contact us at info@pureglobal.com, visit https://pureglobal.com/, or explore our FREE AI tools and medical device database at https://pureglobal.ai/.

The U.S. FDA has unexpectedly withdrawn its key guidance on clinical evaluation for Software as a Medical Device (SaMD). This sudden move has created significant uncertainty for digital health and AI technology developers, leaving many to question if their existing product validation strategies are still viable. This episode of MedTech Global Insights breaks down the immediate impact of this regulatory shift. We explore what this "guidance void" means for companies preparing for FDA submission and how it will reshape the requirements for clinical evidence in the digital health sector. Imagine your SaMD startup is weeks away from a major FDA submission. Suddenly, the core guidance you built your entire clinical strategy upon vanishes overnight. Your planned evidence is now potentially insufficient, and your launch timeline and funding are thrown into chaos. This is the new reality for many innovators that we dissect in this episode. Key Takeaways: - Why did the FDA abruptly withdraw the SaMD clinical evaluation guidance? - What does this "guidance void" mean for SaMD products currently under review? - What new forms of clinical evidence might be required for AI-powered diagnostics? - How does this regulatory action change the risk assessment for software devices? - Should you pause your upcoming SaMD submission to the FDA? - What is the difference between the old framework and the FDA’s likely new expectations? - How can you de-risk your regulatory strategy in light of this uncertainty? 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/.

The FDA's new Quality Management System Regulation (QMSR) is finally here, aligning US regulations with the global ISO 13485 standard. While this promises streamlined compliance for manufacturers, it also introduces subtle but critical new challenges. This episode goes beyond the surface-level news of harmonization. We uncover the dangerous assumption that existing ISO 13485 certification equals automatic QMSR compliance and highlight the specific gaps that could lead to inspection failures. A real-world example is a device manufacturer with CE marking and ISO 13485 certification. They enter the US market assuming they are ready for the new QMSR. During an FDA inspection, they receive a warning letter because their risk management process, while compliant for the EU, isn't integrated into their supply chain and production controls as required by the FDA's interpretation. This is the hidden pain point this episode addresses. Key Questions Answered: - Why isn't your current ISO 13485 certificate a free pass for the new FDA QMSR? - What specific FDA requirements are not covered by the standard ISO 13485? - How does the QMSR change the FDA's approach to risk management during inspections? - What is the single biggest mistake companies make when updating their QMS? - How must you adapt your supplier management and design controls to comply? - What are the new expectations for management responsibility and documentation? - Is your risk management a continuous process or just a static document? 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.

This week on MedTech Global Insights, we dissect the wave of "Refuse to Accept" letters from the US FDA that are derailing market entry plans. As the agency fully enforces its new cybersecurity mandates, many MedTech companies are finding their submissions unexpectedly rejected, causing costly delays and forcing a rethink of their entire regulatory strategy. We explore the critical gap between existing technical documentation and the FDA's stringent new requirements. This episode moves beyond the headlines to reveal the specific, on-the-ground mistakes companies are making, from incomplete software documentation to flawed post-market planning. We use the real-world example of a European AI device company that was blocked from the US market last week, not because of its technology, but because of a single overlooked detail in its cybersecurity file, a painful lesson in the new realities of global regulation. Key Questions Answered: - Why are even top-tier companies getting "Refuse-to-Accept" letters from the FDA? - What is the single biggest mistake companies make in their cybersecurity documentation? - How can you leverage your EU MDR technical file for an FDA submission, and where does it fall short? - Is your Software Bill of Materials (SBOM) actually compliant with FDA expectations? - What specific details does the FDA require in a post-market surveillance plan? - How does threat modeling for the FDA differ from other regulatory bodies? - What are the hidden costs of an RTA letter beyond the regulatory delay? 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.