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
  • AI in MedTech Regulatory Affairs: Scaling to 30+ Global Markets

    AI in MedTech Regulatory Affairs: Scaling to 30+ Global Markets
    Nov 24 2025
    This episode explores how Artificial Intelligence is revolutionizing the medical device registration process, breaking down financial barriers and enabling broader global market access. We discuss the shift from costly, manual submissions to an efficient, technology-driven model that allows MedTech companies of all sizes to bring life-saving innovations to patients worldwide. Learn how AI is not just a tool for efficiency but a force for democratizing global healthcare access. Key Questions: - How can AI drastically reduce the cost of medical device registration? - What are the traditional barriers preventing MedTech companies from entering global markets? - How does lowering registration costs impact patient access to life-saving devices? - Can AI help you bring 10 times more products to 10 times more countries? - Which global markets can be navigated using AI-powered regulatory intelligence? - What specific tasks in the regulatory submission process can be automated? - How is technology making global compliance accessible for startups and smaller companies? Pure Global offers end-to-end regulatory solutions for MedTech and IVD companies, leveraging AI and local expertise to accelerate global market access. We help you develop regulatory strategies, compile technical dossiers with advanced AI, and act as your local representative in over 30 markets. Our goal is to make global expansion efficient and affordable, from initial strategy to post-market surveillance. Visit us at https://pureglobal.com, contact info@pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai to start your journey.
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    3 m
  • Free AI Agents: The Future of Medical Device Registration in the US, EU, and Beyond

    Free AI Agents: The Future of Medical Device Registration in the US, EU, and Beyond
    Nov 23 2025
    This episode explores the transformative impact of free AI-powered tools on the medical device industry. We discuss how making regulatory intelligence and global device databases accessible at no cost is breaking down financial barriers, enabling MedTech companies to expand their reach into new international markets more efficiently and affordably. This shift promises to accelerate the availability of life-saving technologies to patients around the world. - How is Artificial Intelligence revolutionizing the MedTech regulatory landscape? - What if you could access global medical device registration databases for free? - Can AI genuinely lower the cost of market entry for life-saving devices? - What specific AI-powered tools are now available to streamline compliance in over 30 markets? - How can your company leverage free AI for device classification and regulatory pathway analysis? - What is the vision behind making core regulatory AI agents completely free? - How does this shift impact market access in regions like South America, Asia, and Africa? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, leveraging advanced AI to streamline global market access. We help you identify the best markets, develop efficient regulatory strategies, and use AI to compile and submit technical dossiers. Our integrated approach allows a single registration process to unlock multiple international markets, supported by local experts in over 30 countries. Whether you're a startup or a multinational enterprise, our technology-driven solutions accelerate your time-to-market. Explore our free AI tools and databases at https://pureglobal.ai, visit our website at https://pureglobal.com, or contact us at info@pureglobal.com.
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    3 m
  • Colombia Medical Device Registration: Unpacking Decree 4725 of 2005

    Colombia Medical Device Registration: Unpacking Decree 4725 of 2005
    Nov 22 2025
    This episode provides a detailed overview of Colombia's foundational medical device regulation, Decree 4725 of 2005. We explore the critical role of INVIMA, the risk-based classification system, key submission requirements for market approval, and post-market surveillance obligations for MedTech and IVD manufacturers looking to enter the Colombian market. Key Questions - What is Decree 4725 and why is it essential for market access in Colombia? - How does INVIMA classify medical devices based on risk? - What are the core components of a technical dossier for submission in Colombia? - Is a local legal representative required to register a medical device in Colombia? - What are a manufacturer's post-market surveillance responsibilities under Colombian law? - How does Colombia's regulatory framework compare to others globally? - What are the first steps to begin the medical device registration process in Colombia? Pure Global offers end-to-end regulatory consulting solutions for MedTech and IVD companies targeting Latin America. We act as your local representative in Colombia, developing efficient regulatory strategies to navigate INVIMA's requirements under Decree 4725. Our experts and advanced AI tools streamline the compilation and submission of your technical dossier, helping you access the Colombian market faster. Whether you are a startup or a multinational, we ensure your market entry and post-market activities are fully compliant. Contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.
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    3 m
  • Mexico's Technovigilance: Mastering COFEPRIS NOM-240 for Post-Market Success

    Mexico's Technovigilance: Mastering COFEPRIS NOM-240 for Post-Market Success
    Nov 21 2025
    This episode provides a detailed overview of Mexico's Technovigilance requirements for medical devices under COFEPRIS regulation NOM-240-SSA1-2012. We explore the mandatory post-market surveillance system, including the roles of the Sanitary Registration Holder, adverse event reporting timelines, and the documentation required for registration renewal. We also discuss the significant updates proposed in the draft 2024 version of the standard, which will impact software devices and distributor obligations. - What is Technovigilance and why is it mandatory for medical devices in Mexico? - Who is responsible for reporting adverse events to COFEPRIS? - What are the specific reporting deadlines for serious and non-serious incidents? - How does post-market surveillance impact the 5-year renewal of your sanitary registration? - What is the function of a Mexico Registration Holder (MRH) in the Technovigilance process? - What key changes are introduced in the draft PROY-NOM-240-SSA1-2024? - Will Software as a Medical Device (SaMD) be covered under the new Technovigilance rules? - What are the core components of a compliant Technovigilance unit? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access. We act as your local representative in over 30 markets, including Mexico, managing your registration and Technovigilance obligations. Our experts develop efficient regulatory strategies and use advanced AI to compile technical dossiers, ensuring compliance with bodies like COFEPRIS. Let us help you maintain your market presence with continuous regulatory monitoring and post-market surveillance support. For a seamless path to market, contact us at info@pureglobal.com, visit our website at https://pureglobal.com, or explore our free AI tools at https://pureglobal.ai.
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    3 m
  • Mexico's New Medical Device Labeling Standard: A Deep Dive into NOM-137-SSA1-2024

    Mexico's New Medical Device Labeling Standard: A Deep Dive into NOM-137-SSA1-2024
    Nov 20 2025
    This episode provides a critical update on Mexico's new mandatory standard for medical device labeling, NOM-137-SSA1-2024. The host breaks down the key changes from the previous 2008 version, including the strict Spanish language requirement, new provisions for electronic labeling and Software as a Medical Device (SaMD), and updated rules for symbols and date formats. We cover the official publication and effective dates, helping manufacturers understand the timeline for compliance to maintain market access in Mexico. - What is the new mandatory labeling standard for medical devices in Mexico? - When does NOM-137-SSA1-2024 officially come into effect? - Are English labels still acceptable in Mexico under the new regulation? - How does the new standard address electronic labeling and Software as a Medical Device (SaMD)? - What are the specific requirements for displaying expiration dates and using symbols? - What happens if my device labeling is not compliant by the deadline? - How does this 2024 update differ from the previous NOM-137-SSA1-2008? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies. We streamline global market access using a blend of local expertise and advanced AI. Whether you're navigating Mexico's new NOM-137 standard or expanding into any of our 30+ markets, our team can help with regulatory strategy, technical dossier submission, and post-market surveillance. Our technology-driven approach ensures efficiency and accuracy, helping you get to market faster. Explore our services at https://pureglobal.com, contact us at info@pureglobal.com, or access our FREE AI tools and database at https://pureglobal.ai.
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    3 m