『Medical Device Global Market Access』のカバーアート

Medical Device Global Market Access

Medical Device Global Market Access

著者： 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
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  • Guangzhou 2024: Inside China's 5G Smart Hospital Revolution

    Guangzhou 2024: Inside China's 5G Smart Hospital Revolution
    2025/07/16
    This episode dives into the upcoming Greater Bay Area International Medical Device Expo in Guangzhou, China, scheduled for September 23-25. We explore the event's core themes of "Smart Hospitals" and "5G Medical Ecology," detailing how these trends are shaping the future of MedTech in one of the world's most dynamic economic zones. This is a must-listen for professionals seeking to understand and penetrate the advanced Chinese healthcare market. Key Questions: • What makes China's Greater Bay Area a critical hub for MedTech innovation? • How is 5G technology transforming hospital infrastructure and patient care in the region? • What are the key opportunities at the Guangzhou expo from September 23rd to 25th? • Why is understanding the "Smart Hospital" concept, or 智慧医院, essential for market entry in China? • How can you connect with over 500 exhibitors and key regional stakeholders? • What specific digital health and connected device trends are dominating the GBA market? • Are you prepared to navigate the unique regulatory landscape of this powerful economic zone? 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
  • Inside Riyadh's 2024 Global Health Exhibition: Your Gateway to Saudi MedTech

    Inside Riyadh's 2024 Global Health Exhibition: Your Gateway to Saudi MedTech
    2025/07/15
    This episode dives into the 2024 Global Health Exhibition in Riyadh, the largest healthcare event in Saudi Arabia. We explore how this event serves as a crucial gateway for medical device companies looking to capitalize on the Kingdom's Vision 2030, focusing on opportunities in government procurement, high-end equipment imports, and partnerships driven by massive national investment in healthcare transformation. • Why is the Global Health Exhibition a must-attend event for MedTech in 2024? • How is Saudi Arabia's Vision 2030 creating opportunities for medical device manufacturers? • What are the key dates and themes for this year's event in Riyadh? • Which technology sectors, like AI and digital health, are a major focus for investment? • How can companies connect with government procurement bodies and key investors? • What makes this year's exhibition the largest and most significant one yet? • What is the "Invest in Health" theme and what does it mean for market access? 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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    2 分
  • Your Gateway to Japan's Healthcare Market: Navigating MEDICAL JAPAN 2025

    Your Gateway to Japan's Healthcare Market: Navigating MEDICAL JAPAN 2025
    2025/07/14
    This episode provides a detailed guide to the upcoming MEDICAL JAPAN trade show in Tokyo, a vital event for MedTech companies targeting the Japanese and Asian markets. We explore the event's scale, the diverse sectors it covers, and the strategic opportunities it offers for networking, partnerships, and market entry. Key Questions: • What is MEDICAL JAPAN and why is it considered a gateway to Asia's healthcare industry? • When and where will the MEDICAL JAPAN 2025 Tokyo event take place? • How many exhibitors and visitors are expected to attend? • Which six specialized expos are featured within the main event? • What types of products, from precision surgical instruments to digital health, will be on display? • What makes this event essential for finding distributors and partners in Japan? • Are there new, specialized fairs for emerging sectors like aesthetic medicine? • How can attending help your company understand market trends and regulatory requirements? 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

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