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
  • MedTech Goes Global: Top 3 Expansion Strategies

    MedTech Goes Global: Top 3 Expansion Strategies
    Jun 8 2025
    This episode delves into the three essential pillars for medical device companies aiming to expand their reach from local to international markets. We discuss the critical nature of understanding diverse international regulatory landscapes and the role of harmonization efforts. We also explore the importance of in-depth market research, effective product localization, and cultural adaptation. Finally, we cover the strategic value of forming local partnerships and developing a robust go-to-market plan to ensure successful global entry and adoption. Key Questions: • How can you effectively navigate complex international medical device regulations? • What are the latest global harmonization trends, like IMDRF and MDSAP, and their benefits for 2024 and beyond? • Why is deep market research indispensable before launching your medical device globally? • What does comprehensive localization involve to ensure your device resonates in new markets? • How can strategic partnerships unlock doors and accelerate your entry into foreign markets? • What key elements should your go-to-market strategy include for global success? • How do you adapt your medical device and messaging for different cultural and healthcare environments? 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
  • CE Marking: The Golden Key for Global MedTech Entry

    CE Marking: The Golden Key for Global MedTech Entry
    Jun 7 2025
    CE marking is a crucial certification for medical devices, acting as a legal key to the European market and a global benchmark for safety and quality. It signifies compliance with strict EU regulations (MDR/IVDR), offers competitive advantages, and provides a solid foundation for other international regulatory approvals, making it essential for manufacturers aiming for worldwide market access. Key Questions: • Why is CE marking mandatory for selling medical devices in the 30+ countries of the European Economic Area? • How do the EU's MDR and IVDR ensure that CE-marked devices meet high safety and quality standards? • In what ways does CE marking facilitate market access in regions beyond Europe, such as Asia and Latin America? • What are the primary commercial and competitive benefits for manufacturers whose devices bear the CE mark? • How can the documentation prepared for CE marking assist in obtaining regulatory approval in other major markets like the US or China? • Why is CE marking considered a strategic investment rather than just a regulatory compliance step? • What specific assessments must a medical device undergo to qualify for CE marking? • How does CE marking build trust with healthcare professionals and patients globally? 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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    5 mins
  • Decoding High-Risk Medical Device Classifications Worldwide

    Decoding High-Risk Medical Device Classifications Worldwide
    Jun 6 2025
    This episode unpacks the significant variations in "Class III" and "Class IV" medical device classifications across key global markets like the US, EU, Canada, China, and Saudi Arabia. We explore why a device's risk class in one country doesn't automatically apply elsewhere and what this means for manufacturers seeking international market access. Key Questions: • Why isn't a Class III device in the USA treated the same as a Class III in the European Union or Canada? • Which major global markets utilize a Class IV for medical devices, and what specific risks does it cover? • How do fundamental risk definitions for medical devices differ from one regulatory authority to another? • What are the direct regulatory and compliance implications for manufacturers due to these classification differences? • Does the US FDA recognize a Class IV for medical devices, or is Class III its highest tier? • How does the EU's Medical Device Regulation (MDR) categorize its most critical, high-risk devices? • What distinguishes Canada's Class IV medical devices from its Class III devices in terms of risk and scrutiny? • How should medical device companies strategically approach global registration considering these diverse classification systems? 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
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