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  • From EC REP to EU REP: Decoding Critical Medical Device Symbol Changes

    From EC REP to EU REP: Decoding Critical Medical Device Symbol Changes
    2025/07/24
    This episode breaks down the essential updates from ISO 15223-1:2021 and its recent 2025 amendment. We explore the new symbols for medical devices, translations, and sterilization, and detail the critical shift from the 'EC REP' to the 'EU REP' symbol, explaining the reasons and the compliance timeline for manufacturers. Key Questions: • What is ISO 15223-1:2021 and why is it essential for medical device labeling? • Which new symbols were introduced in the latest version? • Why is the 'EC REP' symbol being replaced by 'EU REP'? • What is the official publication date of the amendment changing the authorized representative symbol? • Do you need to immediately relabel all your existing products? • What does 'harmonization' mean and how does it affect your compliance timeline? • How should manufacturers strategically plan for this transition? • What are the implications of the new 'MD' and 'Translation' symbols? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    3 分
  • Unpacking IEC 60601-1 Edition 3.2: The New Standard for Electrical Safety

    Unpacking IEC 60601-1 Edition 3.2: The New Standard for Electrical Safety
    2025/07/23
    This episode breaks down the critical updates in IEC 60601-1 Edition 3.2, the mandatory electrical safety standard for medical devices. We cover the key changes from Amendment 2, including alignment with ISO 14971, the adoption of IEC 62368-1 for IT equipment, and refined requirements for Means of Protection (MOP), helping manufacturers understand the impact on new device submissions, particularly since the FDA's enforcement date of December 17, 2023. • What is the primary goal of IEC 60601-1 and its latest update, Edition 3.2? • When did the FDA officially mandate compliance with Edition 3.2 for new device submissions? • How does the new edition change the requirements for information technology equipment integrated into medical devices? • What are the key differences between Means of Operator Protection (MOOP) and Means of Patient Protection (MOPP)? • Are components like opto-couplers now subject to new, specific requirements? • How has the standard evolved to better align with risk management principles from ISO 14971? • What are the updated requirements for fire enclosures and temperature limits? • Does my existing risk management file need to be updated to comply with Edition 3.2? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    4 分
  • The Golden Key: How ISO 13485 Unlocks Global MedTech Markets

    The Golden Key: How ISO 13485 Unlocks Global MedTech Markets
    2025/07/22
    This episode demystifies ISO 13485:2016, the internationally recognized standard for Quality Management Systems (QMS) in the medical device industry. We explore the standard's core requirements, the critical changes introduced in the 2016 revision, and why compliance is the essential key for any MedTech company aiming to achieve regulatory approval and unlock access to markets across the globe, from the EU to the United States. Key Questions • What is ISO 13485 and how does it differ from the more general ISO 9001? • What critical updates were introduced in the March 2016 revision of the standard? • Why is a risk-based approach now central to the entire medical device lifecycle? • How does ISO 13485 serve as a passport to major global markets? • Is ISO 13485 certification a mandatory legal requirement? • What is the Medical Device Single Audit Program (MDSAP) and what is its connection to ISO 13485? • How is the US FDA aligning its Quality System Regulation (QSR) with this international standard? • What are the essential components of a compliant QMS, from design controls to post-market surveillance? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    4 分
  • Intuitive's Newest Robot: A Surgeon's Sense of Touch

    Intuitive's Newest Robot: A Surgeon's Sense of Touch
    2025/07/21
    This episode unpacks the landmark FDA clearance of Intuitive Surgical's da Vinci 5, the next generation in soft-tissue robotics. We explore its groundbreaking features, including Force Feedback technology that gives surgeons a sense of touch, a 10,000-fold increase in computing power, and enhanced 3D visualization. We also analyze its strategic importance in a competitive market and what it means for the future of surgery. Key Questions: • What is the most significant upgrade in Intuitive's da Vinci 5 system? • How does Force Feedback technology change the game for robotic surgery? • When did the FDA clear this new-generation device for the market? • Why is 10,000 times more computing power a critical feature? • How does the da Vinci 5 aim to improve OR workflow and efficiency? • What does this launch mean for competitors in the surgical robotics space? • How might this new technology impact patient outcomes? • What is Intuitive's strategy for rolling out the da Vinci 5? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    3 分
  • From Lab to Life: The Rise of Bioactive 3D-Printed Spinal Implants

    From Lab to Life: The Rise of Bioactive 3D-Printed Spinal Implants
    2025/07/20
    This episode delves into the revolutionary world of personalized 3D-printed spinal implants, highlighting Xenco Medical's TrabeculeX Continuum. We explore how its bioactive matrix eliminates the need for painful bone grafts, significantly reducing surgery time, and how its integrated recovery app is transforming postoperative care through remote monitoring and high patient engagement. Key Questions: • How can 3D printing revolutionize spinal implant surgery? • What are bioactive materials and how do they eliminate the need for bone grafting? • Can a medical device really reduce spinal surgery time by over 30 minutes? • How is digital health being integrated directly with surgical implants for better outcomes? • What does the future of postoperative recovery look like with remote monitoring apps? • Why was Xenco Medical named one of the world's most innovative companies in 2023? • How can high patient engagement with a recovery app transform the rehabilitation journey? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    3 分
  • The Remote Revolution: How At-Home Devices Are Solving the Physical Therapy Crisis

    The Remote Revolution: How At-Home Devices Are Solving the Physical Therapy Crisis
    2025/07/19
    This episode explores the rise of remote physical therapy devices like ROMTech's PortableConnect as a direct response to the significant shortage of physical therapists in the United States. We analyze the market drivers, patient benefits, and the critical market access hurdles, including payer reimbursement, that innovative MedTech companies face when introducing disruptive technologies. Key Questions: • What does the latest data from October 2024 reveal about the physical therapist shortage in the U.S.? • How does tele-rehabilitation technology aim to bridge the gap in patient care? • What is the ROMTech PortableConnect, and how does it function? • Can at-home devices truly deliver outcomes comparable to traditional, in-person physical therapy? • What are the reported cost savings for patients using remote therapy devices? • Why has prescription growth for these devices increased by 36% year-over-year? • What is the current stance of major insurance payers on reimbursing for this technology? • What regulatory and market access challenges do innovators in this space encounter? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    3 分
  • From Niche to Mainstream: The AI Revolution in Wearable Health Tech

    From Niche to Mainstream: The AI Revolution in Wearable Health Tech
    2025/07/19
    This episode explores the rapid expansion of AI-integrated wearables, focusing on how continuous glucose monitors (CGMs) are transitioning from clinical devices to mainstream wellness tools. We delve into the technological drivers, such as advanced sensors and on-device AI, and the market catalysts, including the 2024 Medicare coverage expansion, that are fueling a 25.53% CAGR in the wearable medtech market. • How are wearables evolving from simple trackers to predictive health monitors? • Why are continuous glucose monitors (CGMs) no longer just for people with diabetes? • What role does Artificial Intelligence (AI) play in real-time health analytics? • Which new over-the-counter devices from companies like Abbott and Dexcom are leading this trend in 2024? • How is the expansion of Medicare coverage accelerating the adoption of wearable medtech? • What does a 25.53% CAGR mean for the future of the wearable medical technology market? • Can these devices truly predict health events before they happen? • What do manufacturers need to know about the regulatory landscape for these new wellness devices? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    3 分
  • AI and the Heart: How 3D Modeling is Transforming Cardiac Diagnosis

    AI and the Heart: How 3D Modeling is Transforming Cardiac Diagnosis
    2025/07/18
    This episode delves into the revolutionary HeartFlow platform, an AI-powered diagnostic tool that creates personalized 3D models of the heart from CT scans. We explore how this technology is transforming the diagnosis of coronary artery disease by offering a non-invasive, highly accurate alternative to traditional methods, its key regulatory milestones with the FDA, and its rapid adoption in leading U.S. hospitals. Key Questions: • How can artificial intelligence create a 3D digital twin of a patient's heart? • What makes AI-powered diagnostics 95% accurate in identifying coronary artery disease? • How does this technology help clinicians distinguish between different types of plaque? • What were the key FDA clearances in 2014 and 2022 that expanded this platform's capabilities? • Why is a CMS reimbursement decision crucial for the market access of a new medical device? • How does providing anatomy, physiology, and plaque data in one test change patient care? • What has led 84% of top U.S. cardiac hospitals to adopt this technology? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    3 分