Episodes

  • EU Medical Device Cybersecurity: Navigating MDCG 2019-16 Under MDR & IVDR

    EU Medical Device Cybersecurity: Navigating MDCG 2019-16 Under MDR & IVDR
    Feb 6 2026
    This episode delves into the critical requirements for medical device cybersecurity in the European Union. We explore the concept of "state of the art" as defined by the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), focusing on the key guidance document, MDCG 2019-16 Rev. 1. Learn how this guidance impacts your design controls, risk management, post-market surveillance, and change management processes to avoid common and costly audit nonconformities. - What does "state of the art" mean for medical device cybersecurity in the EU? - Why is MDCG 2019-16 Rev. 1 a critical document for your technical file? - How do you integrate "secure by design" principles into your product lifecycle? - Are your post-market surveillance activities adequately addressing cybersecurity vulnerabilities? - When does a cybersecurity patch trigger a significant change notification to your Notified Body? - What are the most common cybersecurity-related nonconformities in MDR and IVDR audits? - How does vulnerability handling connect to your vigilance reporting obligations? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies. We develop efficient regulatory strategies and use advanced AI to compile and submit technical dossiers, ensuring compliance with complex requirements like cybersecurity. Our experts provide continuous regulatory monitoring to keep you ahead of changes that impact your market access. With a presence in over 30 markets, we act as your local representative, managing post-market surveillance and ensuring ongoing compliance. Let us help you navigate the global landscape. Contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.
    Show More Show Less
    3 mins
  • EU AI Act & MDR/IVDR: Decoding the New Dual Compliance Roadmap for AI Medical Devices

    EU AI Act & MDR/IVDR: Decoding the New Dual Compliance Roadmap for AI Medical Devices
    Feb 5 2026
    This episode explores the critical intersection of the new European Union AI Act and the existing Medical Device and In-Vitro Diagnostic Regulations (MDR/IVDR). We unpack the challenges of dual compliance for manufacturers of AI-enabled medical devices and explain how the recent joint guidance from the Medical Device Coordination Group and the Artificial Intelligence Board (MDCG 2025-6 / AIB 2025-1) provides a much-needed roadmap for integrating these two complex regulatory frameworks. Key Questions: - What is the EU AI Act and how does it specifically impact medical device manufacturers? - How do the requirements of the AI Act overlap with the existing MDR and IVDR? - What new information must be included in your technical documentation for an AI-enabled device? - How should risk management under ISO 14971 be integrated with the AI Act's risk framework? - What are the new post-market monitoring obligations specifically for AI systems? - Will your current Notified Body be able to assess your device for AI Act compliance? - What are the key deadlines that manufacturers need to be planning for right now? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, combining local expertise with advanced AI to streamline global market access. We develop efficient regulatory strategies, act as your local representative in over 30 markets, and use powerful data tools to compile technical dossiers and monitor regulatory changes. To access global markets faster, visit us at https://pureglobal.com or contact info@pureglobal.com. Be sure to explore our FREE AI tools and extensive regulatory database at https://pureglobal.ai to support your compliance activities.
    Show More Show Less
    3 mins
  • EU SaMD Regulations: Mastering App Store Compliance and 'Making Available' Rules

    EU SaMD Regulations: Mastering App Store Compliance and 'Making Available' Rules
    Feb 4 2026
    This episode explores the critical new regulatory focus from Europe's Medical Device Coordination Group (MDCG) on Software as a Medical Device (SaMD) distributed via online platforms. We discuss how the concept of 'making available on the market' now directly applies to app stores, forcing manufacturers to integrate platform listings, version control, and geographic restrictions into their core compliance and Quality Management Systems to avoid significant penalties. Key Questions: - What does 'making available on the market' mean for a medical app? - How can your app store listing create a serious compliance risk? - Are you responsible for ensuring only the correct version of your SaMD is downloadable? - How do you manage updates and change notices for an app distributed to thousands of users? - Can you use an app store's geographic restrictions to manage regulatory approvals? - What are the consequences of non-compliance for SaMD on digital marketplaces? - How does this new guidance impact your Quality Management System (QMS)? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access with a powerful combination of local expertise and advanced AI. For SaMD innovators, our experts develop efficient regulatory strategies and help manage technical dossiers for submission to authorities worldwide. We ensure your product remains compliant through post-market surveillance and continuous regulatory monitoring. Our AI-powered data tools can accelerate your research and document management. Let us help you navigate the complexities of global expansion. Visit us at https://pureglobal.com, contact info@pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai.
    Show More Show Less
    3 mins
  • EU Legacy Devices: Navigating the 'Significant Change' Maze Under MDR & IVDR

    EU Legacy Devices: Navigating the 'Significant Change' Maze Under MDR & IVDR
    Feb 3 2026
    This episode delves into the critical definition of a "significant change" for legacy medical devices and IVDs under the EU MDR and IVDR. We explore the official MDCG guidance, outlining what types of modifications can end a device's transitional grace period, forcing an early and costly move to full certification. Learn about the high-stakes impact on market access and the importance of a robust change control process. - What is a "legacy device" and what are the new transition timelines? - How can a minor change to a device jeopardize its EU market access? - What is the difference between a significant and non-significant change? - Which MDCG guidance documents are essential for your change control process? - Why is changing a supplier a regulatory grey area? - What are the immediate consequences if a change is deemed significant? - How should you document and justify changes to your Notified Body? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies. We specialize in navigating complex transitions like the EU MDR and IVDR, offering services in Regulatory Strategy, Technical Dossier preparation, and Continuous Regulatory Monitoring to ensure your products remain compliant. Our unique combination of local expertise in over 30 markets and advanced AI tools streamlines global market access. Let us help you manage change control and maintain your market presence without disruption. Visit https://pureglobal.com, contact us at info@pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.
    Show More Show Less
    3 mins
  • Beyond the Barcode: Mastering MedTech UDI for EUDAMED & Global Markets

    Beyond the Barcode: Mastering MedTech UDI for EUDAMED & Global Markets
    Feb 2 2026
    This episode delves into the complex realities of Unique Device Identification (UDI) strategy for medical devices. The host explores common blockers that go beyond simple barcode generation, including the nuanced rules for UDI assignment across different packaging configurations, the challenges of carrier placement, and the critical importance of database submission readiness for platforms like EUDAMED. We uncover why mistakes in UDI can cascade into significant traceability and recall issues, and discuss strategies for harmonizing labels across multiple international markets. Key Questions: - Why is UDI strategy more than just generating a number? - How do UDI requirements differ for individual devices versus kits or procedure packs? - What are the most common mistakes in assigning UDIs to different packaging levels? - How can you harmonize device labels for both US FDA and EU MDR compliance? - What makes EUDAMED data submission a critical blocker for market access? - How do UDI errors impact supply chain traceability and product recalls? - What are the rules for placing the UDI carrier on labels versus the device itself? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access with local expertise and advanced AI tools. We help develop efficient regulatory pathways, manage technical dossier submissions, and act as your local representative in over 30 markets. Our technology-driven approach enhances the accuracy and speed of compliance, from initial strategy to post-market surveillance. Let us help you navigate complex requirements and accelerate your international expansion. Contact Pure Global at info@pureglobal.com, visit us at https://pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.
    Show More Show Less
    3 mins
  • EU MDR Vigilance & Trend Reporting: A Deep Dive into CAPA and FSCA Decisions

    EU MDR Vigilance & Trend Reporting: A Deep Dive into CAPA and FSCA Decisions
    Feb 1 2026
    This episode explores the critical operational hotspots in medical device vigilance under regulations like the EU MDR. We examine the pressures for faster, higher-quality incident investigations, the complexities of making accurate MDR reportability decisions, and the nuances of establishing effective trend reporting thresholds. Discover how these vigilance activities are directly linked to your CAPA system, FSCA decisions, and the overall credibility of your Post-Market Surveillance (PMS) system during Notified Body audits. Key Questions: - How can you speed up incident investigations without sacrificing quality? - What are the key factors in making an accurate MDR reportability decision? - How do you establish meaningful thresholds for trend reporting? - What is the direct link between your vigilance system and your CAPA process? - How do Field Safety Corrective Actions originate from post-market vigilance data? - What will a Notified Body look for when auditing your incident-to-CAPA traceability? - Why is under-reporting incidents just as risky as over-reporting? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access. Our experts help you build robust post-market surveillance and vigilance systems that meet stringent standards like the EU MDR. We develop efficient pathways for compliance, using advanced AI to manage technical dossiers and monitor regulatory changes. From initial strategy and registration to post-market surveillance and quality assurance, Pure Global ensures your products remain compliant and safe. Let us be your local representative and navigate complex vigilance requirements. Visit https://pureglobal.com/, email info@pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.
    Show More Show Less
    4 mins
  • Beyond the Plan: Mastering PMS and PMCF Execution Under EU MDR

    Beyond the Plan: Mastering PMS and PMCF Execution Under EU MDR
    Jan 31 2026
    This episode explores the critical shift in regulatory focus from Post-Market Surveillance (PMS) planning to execution. We discuss why Notified Bodies and regulators, particularly under the EU MDR, are no longer accepting PMS and Post-Market Clinical Follow-up (PMCF) as a paperwork exercise. Learn about the concept of a “silent nonconformity” and how a weak, poorly executed surveillance strategy can lead to major issues during surveillance audits and certificate renewals, jeopardizing your market access. - Why are regulators no longer accepting PMS plans as mere paperwork? - What is a “silent nonconformity” and how can it impact your device certification? - How can you design a PMS plan that generates truly usable signals about your device? - When is a Post-Market Clinical Follow-up (PMCF) study truly justified? - What are Notified Bodies looking for during a surveillance audit of your post-market activities? - How does the EU MDR change the expectations for PMS and PMCF execution? - Are your post-market surveillance activities prepared for the scrutiny of a renewal audit? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies. We streamline global market access by developing efficient regulatory strategies, including robust post-market surveillance and clinical follow-up plans. Our expert teams and advanced AI tools help you manage technical dossiers, monitor regulatory changes, and ensure ongoing compliance in over 30 markets. Avoid costly nonconformities and maintain your market presence with a proactive approach. To learn how we can accelerate your global expansion, visit us at https://pureglobal.com, contact info@pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai.
    Show More Show Less
    3 mins
  • EU MDR Clinical Evidence: Mastering CERs, PMCF, and Equivalence Arguments

    EU MDR Clinical Evidence: Mastering CERs, PMCF, and Equivalence Arguments
    Jan 30 2026
    This episode delves into the stringent clinical evidence requirements under the European Union's Medical Device Regulation (MDR 2017/745). We explore the top challenges manufacturers face, including the heightened standards for clinical evaluation plans and reports (CEPs/CERs), the complexities of justifying 'sufficient data,' the difficulties in making equivalence arguments, and the continuous nature of Post-Market Clinical Follow-up (PMCF). Key Questions - What does "sufficient clinical evidence" truly mean under the EU MDR? - Why are so many companies forced to rewrite their Clinical Evaluation Reports (CERs)? - How have the rules for claiming equivalence to another device changed? - Is Post-Market Clinical Follow-up (PMCF) optional or a continuous requirement? - How do you align your marketing claims, risk management, and PMS data? - What are the biggest clinical data hurdles for borderline and Class IIa/IIb devices? - How can you prepare your clinical evaluation for stricter Notified Body scrutiny? Pure Global streamlines global market access for MedTech and IVD companies navigating complex regulations like the EU MDR. Our experts develop robust regulatory strategies and use advanced AI to efficiently compile technical dossiers and Clinical Evaluation Reports, ensuring alignment with Notified Body expectations. We manage the entire lifecycle, from pre-submission to Post-Market Clinical Follow-up and surveillance, acting as your local representative in over 30 markets. Let us help you meet the high standards for clinical evidence and accelerate your entry into the EU and beyond. Contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.
    Show More Show Less
    3 mins