Medical Device Global Market Access Podcast By Pure Global cover art

Medical Device Global Market Access

Medical Device Global Market Access

By: Pure Global
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 Navigate every market. Accelerate every launch. Medical Device Global Market Access by Pure Global is the audio briefing that turns the world’s most confusing regulatory pathways into clear, actionable roadmaps. If you’re a MedTech founder, RA/QA leader, product manager, or investor who needs to get devices cleared anywhere from Austin to Abu Dhabi, this show is your shortcut. Why listen? • Step-by-step playbooks – We decode EU MDR, U.S. 510(k), Brazil’s ANVISA, China’s NMPA, and 25 + other regimes, showing exactly how long each milestone really takes and where companies get stuck. • First-hand war stories – Hear candid interviews with regulatory veterans who have shepherded implants, software, wearables, diagnostics, and AI algorithms to market—and lived to tell the tale. • Real-time intelligence – Every episode covering the week’s new guidances, standards, and enforcement trends so you’re always ahead of the curve. • Actionable templates – From clinical evaluation checklists to technical-file skeletons, we break down the documents you’ll need and the pitfalls reviewers love to flag. • AI-powered insights – Because Pure Global mines millions of public filings, tenders, and recalls, we surface data-backed best practices you won’t hear at conferences—or from competitors. What you’ll hear • Launching SaMD under multiple risk classes in parallel • Surviving an unannounced ISO 13485 audit • Building a “reg-first” QMS that scales • Mastering Latin-American registrations without endless language cycles • Leveraging real-world evidence to shorten clinical timelines • Aligning cybersecurity, privacy, and post-market surveillance rules across regions Whether you’re plotting first entry, managing lifecycle expansions, or rescuing a delayed submission, subscribing could shave months—and millions—off your path to revenue. ⸻ Brought to you by Pure Global – the AI-native consultancy that already guides MedTech innovators through regulatory and market-access hurdles in 30 + countries. Ready for expert help on your next submission? Visit https://pureglobal.com or email info@pureglobal.com to start accelerating today.Copyright 2025 Pure Global
Episodes
  • Beyond the Hospital: The Rise of Long-Term Care Devices

    Beyond the Hospital: The Rise of Long-Term Care Devices
    Jul 4 2025
    This episode delves into the rapidly growing Long-Term Care (LTC) market, explaining what it is, the demographic shifts driving its expansion, and its critical link to the medical device industry. We explore the evolution from basic equipment to advanced technologies like IoT, remote patient monitoring, and AI, highlighting the future trends and opportunities for MedTech manufacturers. • What is Long-Term Care (LTC) and why is it becoming a critical healthcare sector? • What global demographic trends are causing the LTC market to skyrocket? • How large is the market projected to be by 2030? • How is the role of medical devices in LTC evolving beyond basic mobility aids? • What are the key technology trends, like remote monitoring and telehealth, shaping the future of care? • How will Artificial Intelligence transform device capabilities and patient outcomes? • Why is the "aging in place" phenomenon a major opportunity for MedTech innovation? • What new types of devices are in high demand for home healthcare settings? 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 mins
  • Beyond the Great Wall: Unlocking China's Medical Device Market in 2025

    Beyond the Great Wall: Unlocking China's Medical Device Market in 2025
    Jul 3 2025
    China's medical device market is poised for significant growth leading into 2025, driven by an aging population and government initiatives like "Healthy China 2030." However, foreign manufacturers face new challenges, including fierce local competition, pro-domestic procurement policies, and the complexities of the NMPA regulatory system. This episode breaks down the market outlook for 2025, exploring the key drivers, the critical challenges, and the localized strategies required to succeed in this evolving landscape. Key Questions: • What are the latest growth forecasts for China's MedTech market in 2025 and beyond? • How is the "Healthy China 2030" policy impacting opportunities for foreign companies? • Why is a "Made in China" strategy becoming essential for market access? • What are the biggest regulatory hurdles presented by the NMPA? • How is the rise of local competitors and Volume-Based Procurement (VBP) affecting pricing and strategy? • Which device categories, such as AI and robotics, show the most promise for foreign brands? • What are the most effective market entry models for navigating the 2025 landscape? • Is it still possible for international medical device companies to succeed in China? 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 mins
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