Medical Device Global Market Access Podcast Por Pure Global arte de portada

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
Episodios
  • MedTech Market Entry: The True Cost of Free vs. Paid Regulatory Resources

    MedTech Market Entry: The True Cost of Free vs. Paid Regulatory Resources
    Nov 27 2025
    This episode breaks down the crucial differences between free and paid resources in the complex world of medical device market access. We explore what you can achieve with publicly available information from regulatory bodies and when it becomes essential to invest in expert services for strategy, submission, and reimbursement to ensure a successful product launch. - What essential regulatory information is available for free? - Are government websites and databases sufficient for building a full market entry strategy? - When does it become critical to invest in paid consulting and local representation? - How can you determine the return on investment for paid market access services? - What are the hidden costs and risks of relying solely on free resources? - Why is navigating reimbursement and Health Technology Assessment (HTA) bodies impossible without expert support? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies. We combine local expertise in over 30 markets with advanced AI tools to streamline global market access, from initial strategy and technical dossier submission to post-market surveillance. Our integrated approach allows a single registration process to unlock multiple markets, saving you time and resources. Whether you are a startup or a multinational enterprise, our solutions are tailored to get your innovations to patients faster. Contact us at info@pureglobal.com, visit our website at https://pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai.
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    3 m
  • Beyond the SaaS Hype: Real AI-Powered Global Market Access for MedTech

    Beyond the SaaS Hype: Real AI-Powered Global Market Access for MedTech
    Nov 26 2025
    This episode explores the critical distinction between standalone AI SaaS tools and a fully integrated, service-based approach for MedTech global market access. We dissect why expensive software alone often falls short and how combining advanced AI with on-the-ground human expertise, local representation, and end-to-end regulatory services provides a more efficient and effective path to launching and maintaining products in over 30 international markets. Key Questions: - Is your expensive AI SaaS tool actually accelerating your global market access? - What is the critical gap most standalone software solutions leave for your regulatory team? - How can a single registration process unlock access to over 30 countries? - What does an integrated service model offer that a pure SaaS platform cannot? - Why is local, human expertise still irreplaceable in the age of AI? - How can AI be used to empower a global team rather than just automate a single task? - What should you look for in a true global regulatory partner? Pure Global offers the end-to-end solution discussed in this episode. We don't just sell software; we provide a complete partnership for MedTech and IVD companies. Our approach combines advanced AI for efficiency with the critical expertise of local representatives in over 30 markets. From initial regulatory strategy and technical dossier submission to post-market surveillance, we streamline your entire global market access journey. Let us handle the complexities so you can focus on innovation. Contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai to see the difference.
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    3 m
  • MedTech Expansion Strategy: Unlocking Underserved Global Markets in LATAM and APAC

    MedTech Expansion Strategy: Unlocking Underserved Global Markets in LATAM and APAC
    Nov 25 2025
    This episode explores the strategies and regulatory hurdles involved in bringing medical devices to underserved and emerging global markets. We discuss how to leverage existing approvals, the critical role of local representation, and the use of technology to streamline multi-country submissions, focusing on promising regions like Latin America and Southeast Asia. Key Questions: - How can you leverage your existing US or EU approvals to enter new regions? - What are the primary regulatory hurdles in Latin American and Southeast Asian markets? - Why is local representation critical for success in underserved economies? - How can technology streamline submissions for multiple, non-harmonized markets? - What is the first step in identifying the most promising underserved markets for your device? - Is it possible to use a single registration process to access dozens of countries? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access with a unique blend of local expertise and advanced AI. We help you develop efficient regulatory strategies, act as your local representative in over 30 markets, and use AI to compile technical dossiers for faster submissions. Our integrated approach allows a single registration process to unlock multiple international markets simultaneously. To accelerate your global expansion and access our FREE AI tools and regulatory database, visit us at https://pureglobal.ai or contact our team at info@pureglobal.com.
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    3 m
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