『Medical Device Global Market Access』のカバーアート

Medical Device Global Market Access

Medical Device Global Market Access

著者： 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
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  • 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
    2025/11/23
    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 分
  • Colombia Medical Device Registration: Unpacking Decree 4725 of 2005

    Colombia Medical Device Registration: Unpacking Decree 4725 of 2005
    2025/11/22
    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 分
  • Mexico's Technovigilance: Mastering COFEPRIS NOM-240 for Post-Market Success

    Mexico's Technovigilance: Mastering COFEPRIS NOM-240 for Post-Market Success
    2025/11/21
    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 分
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