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
  • FDA's Gatekeeper: A Guide to the U.S. Agent for Foreign MedTech Companies

    FDA's Gatekeeper: A Guide to the U.S. Agent for Foreign MedTech Companies
    Oct 5 2025
    This episode breaks down the mandatory FDA requirement for foreign medical device manufacturers to appoint a U.S. Agent. We explore the specific roles, responsibilities, and qualifications of a U.S. Agent, clarifying their function as the essential communication link between your company and the FDA. Learn the key differences between a U.S. Agent and an Official Correspondent and understand the strategic considerations when choosing your representative to ensure smooth entry into the U.S. market. Key Questions: • What is the primary role of an FDA U.S. Agent? • Is appointing a U.S. Agent an optional or mandatory step for market entry? • Who is required to designate a U.S. Agent? • What are the specific responsibilities of a U.S. Agent during FDA interactions? • How does a U.S. Agent differ from an Official Correspondent? • What are the risks of appointing a distributor as your U.S. Agent? • What duties is a U.S. Agent *not* responsible for? • How is a U.S. Agent officially designated with the FDA? 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
  • The MedTech Partnership Playbook: A Blueprint for Mutual Growth

    The MedTech Partnership Playbook: A Blueprint for Mutual Growth
    Oct 4 2025
    This episode outlines a strategic framework for building powerful and mutually beneficial partnerships in the MedTech industry. We explore how to create a central hub for collaborators and tailor your value proposition to different partner types—from venture capitalists to distributors—all while adhering to core principles like transparency and long-term value. • How can you create a clear and effective partnership strategy? • What is the key to attracting the right type of partners for your MedTech company? • How should you tailor your value proposition for Venture Capital firms? • What do consulting firms look for in a MedTech partner? • How can you build a robust network of distributors and resellers? • What are the core principles that underpin any successful business partnership? • Is your company prepared to manage different types of strategic alliances simultaneously? 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
  • Expand Your Catalog: A Distributor's Guide to Profitable MedTech Partnerships

    Expand Your Catalog: A Distributor's Guide to Profitable MedTech Partnerships
    Oct 3 2025
    This episode provides a roadmap for medical device distributors and resellers looking to add a profitable, in-demand solution to their catalog. We explore the massive growth in the global medical device market, forecast for 2024 and beyond, and break down the key elements of a successful manufacturer-distributor partnership. Learn about the value proposition, from attractive margins to products that practically sell themselves, and discover the essential support systems, including sales training, a full suite of marketing resources, and dedicated channel management, that empower you to succeed. • What does the 2024 data say about the explosive growth of the medical device market? • How can you identify a medical device that will be a profitable addition to your portfolio? • What are the commercial benefits and margin structures you should look for in a partner? • How can a product's key differentiators make the sales process easier for your team? • What should a comprehensive partner program offer to guarantee your success? • Why is a dedicated channel manager crucial for your business development? • What kind of sales training and marketing resources should you expect from a manufacturer? • Are you ready to apply to become a distributor for a leading-edge solution? 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
  • Supercharge Your MedTech Consultancy: Drive Client Success & New Revenue

    Supercharge Your MedTech Consultancy: Drive Client Success & New Revenue
    Oct 2 2025
    In this episode, we explore a powerful partnership model for MedTech consulting firms. Discover how collaborating with Pure Global can enhance your service offerings, help you deliver tangible, data-driven results for your clients, and unlock new revenue streams for your business. We detail the dedicated support, co-marketing opportunities, and sales collateral available to our partners, positioning you to drive unmatched client success in the complex world of global market access. Key Questions: • How can your consulting firm deliver even more value to your MedTech clients? • Are you looking for a best-in-class tool to enhance your current service offerings? • What if you could improve client ROI while reducing their time-to-market? • How can you create new, reliable revenue streams for your consultancy? • What does a dedicated partner support program for consultants look like? • Could co-branded marketing materials help you win more business? • Are you interested in co-marketing opportunities like joint webinars and whitepapers? 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
  • De-Risking MedTech Investments: A VC's Guide to Regulatory Success

    De-Risking MedTech Investments: A VC's Guide to Regulatory Success
    Oct 1 2025
    This episode is dedicated to venture capital firms invested in the medical device sector. We explore how a strategic regulatory partnership is not just an operational service but a critical tool for de-risking investments and accelerating the growth of portfolio companies. We discuss the tangible benefits of early regulatory planning, including faster market entry, enhanced capital efficiency, and a significant competitive advantage, ultimately amplifying the value of your MedTech portfolio. • How can VCs mitigate the significant risks posed by global regulatory hurdles? • What makes a regulatory partner a strategic asset rather than just a service provider? • How does early regulatory planning accelerate a MedTech startup's growth and path to profitability? • In what ways can a regulatory strategy provide a portfolio company with a sustainable competitive edge? • How can VCs leverage regulatory insights for more effective due diligence? • What exclusive benefits can portfolio companies gain from a dedicated partnership? • Is it possible to turn complex global regulations into a predictable advantage for your investments? 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