Couverture de Medical Device Global Market Access

Medical Device Global Market Access

Medical Device Global Market Access

De : 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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    Épisodes
    • The Gatekeepers of Global MedTech: Decoding the FDA, EMA, and NMPA

      The Gatekeepers of Global MedTech: Decoding the FDA, EMA, and NMPA
      Jun 25 2025
      This episode demystifies the world's leading medical device regulatory bodies. We break down the distinct structures, approval pathways, and critical requirements of the FDA (USA), the EMA (EU), and the NMPA (China), providing the essential knowledge needed to begin crafting a global market strategy. Key Questions: • What are the fundamental differences between the FDA's centralized system and the EMA's Notified Body approach? • How does a device's risk classification impact its path to market in the US, EU, and China? • What is a 510(k) clearance, and when is a more stringent Premarket Approval (PMA) required by the FDA? • Why is the CE Mark essential for European market access? • What unique challenges, like local clinical trial requirements, does China's NMPA present? • What is the importance of the FDA's Quality Management System Regulation update, effective February 2, 2026? • What are the roles of other key agencies like Health Canada and Japan's PMDA? 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 min
    • From Stressed to Prepared: A Guide to Acing MedTech Audits

      From Stressed to Prepared: A Guide to Acing MedTech Audits
      Jun 24 2025
      This episode provides a comprehensive, step-by-step guide to achieving and maintaining medical device audit readiness. The host outlines how to move beyond last-minute preparation by embedding a culture of quality and compliance into your daily operations. Key topics include implementing a robust QMS, conducting proactive internal audits, leveraging technology for documentation, and managing the audit process from preparation to post-audit actions. Key Questions: • How can you transform audit preparation from a last-minute scramble into a daily practice? • What are the essential components of a robust Quality Management System that satisfies auditors? • Why are regular internal audits your most powerful tool for proactive compliance? • How do you effectively train your team to be confident and competent during an inspection? • What specific documentation must be perfectly organized and accessible before an auditor arrives? • How can technology streamline your audit readiness and ensure traceability? • What are the key strategies for managing the audit day itself to ensure a smooth process? • How should you respond to audit findings to demonstrate continuous improvement? 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 min
    • South Asia's MedTech Surge: A Guide to Market Trends & Opportunities

      South Asia's MedTech Surge: A Guide to Market Trends & Opportunities
      Jun 23 2025
      This episode provides a comprehensive overview of the South Asian medical device market, highlighting key growth drivers, market size projections, and regulatory trends. We explore the unique dynamics of countries like India, Pakistan, and Bangladesh, comparing the region's trajectory with that of Southeast Asia and identifying the most promising sectors for manufacturers and investors. • How large will the South Asian medical device market be by 2025? • What key factors are fueling the rapid expansion of India's MedTech sector? • How do customer preferences in South Asia balance technology with affordability? • What is the current state of medical device regulation across the region? • How does South Asia's market differ from the more digitally advanced Southeast Asian market? • Which medical device segments are experiencing the fastest growth? • What role is India's 80% import dependency playing in its push for domestic manufacturing? • Where do the biggest opportunities lie for MedTech companies in the coming years? 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 min

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