Couverture de Medical Device Global Market Access

Medical Device Global Market Access

Medical Device Global Market Access

De : Pure Global
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3 mois pour 0,99 €/mois Offre valable jusqu'au 12 décembre 2025. 3 mois pour 0,99 €/mois, puis 9,95 €/mois. Offre soumise à conditions.J'en profite

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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
    • Scaling MedTech: Tailored Regulatory Strategies for Startups, Scaleups, and Global Enterprises

      Scaling MedTech: Tailored Regulatory Strategies for Startups, Scaleups, and Global Enterprises
      Nov 30 2025
      This episode explores how regulatory strategies for MedTech and IVD devices must adapt to a company's growth stage. We discuss the unique challenges and tailored solutions for startups seeking initial market entry, scaleups planning international expansion, and multinational enterprises managing complex global portfolios. Learn how a strategic approach, from agile guidance to AI-powered compliance, can support your company at every step of its journey. - How do the regulatory challenges of a startup differ from those of a multinational enterprise? - What should a fast-growing scaleup look for in a global regulatory partner? - Can a single registration process be leveraged to enter multiple international markets? - How can AI and data tools streamline technical dossier submission and market research? - What are the key strategies for maintaining compliance across a diverse global product portfolio? - Are there cost-effective ways for startups to navigate complex regulations in the EU, US, or Asia? - How can a company choose the right international markets for strategic expansion? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies at every stage of growth. Whether you're a startup needing agile guidance, a scaleup expanding globally, or a multinational enterprise optimizing a complex portfolio, our solutions are designed for your specific needs. We leverage our local expertise in over 30 markets and advanced AI data tools to accelerate your growth, from initial strategy and technical dossier submission to post-market surveillance. Contact Pure Global at info@pureglobal.com, visit us at https://pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.
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      3 min
    • Beyond Traditional Consulting: The Future of IVD and MedTech Market Access

      Beyond Traditional Consulting: The Future of IVD and MedTech Market Access
      Nov 29 2025
      This episode explores the evolution of regulatory consulting for MedTech and IVD devices. We contrast the traditional, fragmented consulting model with Pure Global's integrated, technology-driven approach. Discover how AI, a unified global-local team, and an end-to-end service model are revolutionizing how companies achieve faster, more efficient market access in over 30 countries. - Why does the traditional multi-consultant model often lead to higher costs and delays? - How can a "single process, multiple markets" strategy accelerate your global expansion? - What role does Artificial Intelligence play in compiling technical dossiers and submissions? - How does having dedicated local offices differ from a network of third-party agents? - Can you leverage one partner for everything from initial strategy to post-market surveillance? - What advantages does a database of over 5 million products offer for clinical data analysis? - How is a technology-driven approach changing regulatory affairs from a cost center to a strategic advantage? Pure Global offers end-to-end regulatory solutions for MedTech and IVD companies, combining local expertise with advanced AI to streamline global market access. Our integrated approach enables a single registration process for multiple markets, from the US and EU to Asia. We support startups and multinationals with regulatory strategy, technical submissions, and post-market surveillance. For faster, technology-driven market access, visit https://pureglobal.com or contact info@pureglobal.com. Explore our free AI tools and regulatory database at https://pureglobal.ai.
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      3 min
    • Unlocking Global MedTech Markets: A Unified Strategy for Registration in the US, EU, and Asia

      Unlocking Global MedTech Markets: A Unified Strategy for Registration in the US, EU, and Asia
      Nov 28 2025
      This episode explores how MedTech and IVD companies can overcome the complexities of international expansion. We discuss a unified, technology-driven approach to registering medical devices in over 30 global markets simultaneously, covering everything from initial regulatory strategy and market selection to the role of local representation and AI-powered technical dossier submissions. Key Questions: - How can you enter 30+ global MedTech markets with a single registration process? - What are the critical first steps in developing a global regulatory strategy? - Why is local representation essential for market access in countries like Brazil or South Korea? - How can AI accelerate the creation and submission of your technical dossiers? - What's the key to selecting the most promising international markets for your device? - How do you maintain compliance after your product is approved abroad? - Can one unified approach work for both startups and multinational corporations? Pure Global provides end-to-end regulatory consulting solutions for MedTech and IVD companies, streamlining access to over 30 global markets. We combine local expertise with advanced AI to manage the entire product lifecycle, from regulatory strategy and market selection to technical dossier submission and post-market surveillance. Our unique 'Single Process, Multiple Markets' approach simplifies expansion, saving you time and resources. Whether you're a startup or a multinational, we act as your local representative to ensure a smooth path to commercialization. For expert guidance, visit https://pureglobal.com/, contact info@pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.
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      3 min
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