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
  • Beyond the Mailbox: Your EU Rep's Critical MDR & IVDR Duties

    Beyond the Mailbox: Your EU Rep's Critical MDR & IVDR Duties
    Oct 8 2025
    This episode delves into the critical role of the European Authorised Representative (EC REP) for non-EU medical device and IVD manufacturers under the MDR and IVDR. We explore how the responsibilities have expanded beyond a simple administrative function to include significant legal liability and active compliance verification, making the choice of your EC REP a crucial strategic decision for successful market access. • What is a European Authorised Representative (EC REP)? • Why is appointing an EC REP mandatory for non-EU manufacturers? • How did the MDR and IVDR change the legal liability of the Authorised Representative? • What specific compliance documents must your EC REP verify before you can market your device? • Can your Authorised Representative be held responsible for your defective devices? • What is the relationship between an Authorised Representative and the Person Responsible for Regulatory Compliance (PRRC)? • How does the EC REP participate in post-market surveillance and incident reporting? • What should you look for when selecting an Authorised Representative for the EU market? 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 m
  • Post-Brexit MedTech Compliance: The Crucial Role of the UK Responsible Person

    Post-Brexit MedTech Compliance: The Crucial Role of the UK Responsible Person
    Oct 7 2025
    This episode breaks down the essential post-Brexit requirement for non-UK medical device manufacturers: the UK Responsible Person (UKRP). We explore the legal obligations, key responsibilities in relation to the MHRA, and the critical role the UKRP plays in registering devices, maintaining technical documentation, and facilitating post-market surveillance for access to the market in Great Britain. Key Questions: • What is a UK Responsible Person (UKRP) and why is it mandatory? • Which manufacturers are required to appoint a UKRP to access the market in Great Britain? • What are the primary legal duties and responsibilities of a UKRP? • How does the UKRP interact with the UK's regulatory body, the MHRA? • What specific documentation must the UKRP verify and maintain? • What are the crucial transition deadlines for CE marked devices before the UKCA mark becomes mandatory? • Why is selecting an independent UKRP, rather than a distributor, a strategic advantage? • How does the UKRP support post-market surveillance and vigilance activities? 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 m
  • Brazil's Regulatory Gatekeeper: Navigating the Brazil Registration Holder Requirement

    Brazil's Regulatory Gatekeeper: Navigating the Brazil Registration Holder Requirement
    Oct 6 2025
    This episode provides a comprehensive guide to the Brazil Registration Holder (BRH), a mandatory requirement for foreign medical device manufacturers seeking market access in Brazil. We explore the critical role the BRH plays as the legal holder of the ANVISA registration, detailing their extensive responsibilities from initial submission to post-market surveillance. The discussion emphasizes the strategic importance of choosing between a distributor and an independent third-party representative, highlighting the risks of commercial lock-in versus the flexibility and control offered by an independent partner. Key Questions • What is a Brazil Registration Holder (BRH) and why is it mandatory for ANVISA approval? • What are the legal responsibilities that a BRH assumes for a medical device? • What are the significant risks of appointing a distributor as your BRH? • How does an independent BRH give you more control over your Brazilian commercial strategy? • What key duties does the BRH perform, including B-GMP certification and vigilance reporting? • Which recent ANVISA regulations, like RDC 751/2022, define the current requirements? • Why is transferring a device registration to a new holder often a complex process? • How does the BRH model protect a manufacturer's intellectual property? 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 m
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