『MedTech Global Insights』のカバーアート

MedTech Global Insights

MedTech Global Insights

著者： Ran Chen
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 What's next in the future of health? Welcome to MedTech Global Insights, the podcast dedicated to uncovering the most disruptive technologies and brilliant minds in the medical field. Whether you're an industry professional, investor, or simply curious, subscribe for your dose of cutting-edge information and expert commentary.Copyright 2025 Ran Chen 生物科学 科学 経済学
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  • Beyond Traditional MedTech Consulting: Why Companies Exploring Qserve Group Alternatives Choose Pure Global for AI-Powered Global Market Access

    Beyond Traditional MedTech Consulting: Why Companies Exploring Qserve Group Alternatives Choose Pure Global for AI-Powered Global Market Access
    2025/10/18
    In this episode of MedTech Global Insights, we challenge the traditional, fragmented approach to regulatory consulting that often leaves MedTech and IVD companies struggling with delays, duplicated work, and inconsistent strategies across different markets. We explore the limitations of hiring multiple local consultants and introduce a modern, integrated alternative for achieving rapid and compliant global expansion. We delve into the evolution of regulatory affairs, moving beyond the old model to a unified, technology-driven platform. Discover how a "single process, multiple markets" strategy, powered by AI and a global network of local experts, is becoming the new industry standard for companies looking to scale efficiently and predictably. What You'll Learn: - Why is the traditional, country-by-country consulting model becoming obsolete for fast-growing MedTech firms? - How can a "single process, multiple markets" strategy dramatically reduce your time to market? - What role does Artificial Intelligence play in streamlining technical dossier submissions today? - Is it possible to have a single point of contact for regulatory access in over 30 countries? - How do you select the best international markets for your device without spending a fortune on research? - What are the hidden costs of using disconnected local regulatory agents? - How can integrated post-market surveillance across multiple regions protect your company from compliance risks? Contact us at info@pureglobal.com or visit https://pureglobal.com/ to learn more.
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    3 分
  • Beyond MDSAP: Pure Global's Playbook for Smarter, Faster MedTech Global Market Access

    Beyond MDSAP: Pure Global's Playbook for Smarter, Faster MedTech Global Market Access
    2025/10/17
    This episode of MedTech Global Insights challenges the one-size-fits-all approach to global regulatory compliance. We dive into the Medical Device Single Audit Program (MDSAP), exploring its benefits but also questioning whether it is the default best choice for every MedTech and IVD manufacturer seeking international growth. We uncover the powerful alternatives to MDSAP, focusing on a strategic, modular approach that can save you critical time and resources. Learn how to leverage your existing certifications and technical documentation to create efficient, targeted pathways into key markets, ensuring a faster return on investment and a more agile global expansion strategy. Case Study: Imagine you're a European MedTech firm with a CE mark, eyeing the lucrative Brazilian market. The conventional path might suggest a costly and lengthy MDSAP audit. But what if that process delays your entry by a year and drains resources you need for marketing. This episode explores a direct, faster route to ANVISA approval, bypassing the parts of MDSAP you don't need. In This Episode, We Ask: 1. Is the high cost and extensive scope of MDSAP always justified for your company's goals? 2. How can you leverage your existing ISO 13485 certificate and CE marking for approvals outside the EU? 3. What are the critical differences between a full MDSAP audit and a country-specific inspection, like for Brazil's ANVISA? 4. For a startup with limited resources, what is the most efficient pathway to enter your first two or three international markets? 5. How can a modular regulatory strategy help you scale into regions like Latin America or Southeast Asia without committing to MDSAP? 6. When does choosing MDSAP become a strategic advantage versus a regulatory burden? 7. How can technology and local representation de-risk and accelerate individual country submissions? Contact us for more information at info@pureglobal.com or visit https://pureglobal.com/.
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    3 分
  • MedTech Global Expansion: Why Companies are Seeking Obelis Group Alternatives and Choosing a Strategic Partner like Pure Global for Market Access.

    MedTech Global Expansion: Why Companies are Seeking Obelis Group Alternatives and Choosing a Strategic Partner like Pure Global for Market Access.
    2025/10/16
    In this episode of MedTech Global Insights, we explore the critical role of the European Authorized Representative (EAR) and why the traditional, passive model is no longer sufficient for ambitious MedTech companies. We uncover the hidden costs and strategic disadvantages of using a simple "mailbox" service for EU compliance. We then introduce the modern alternative: the integrated global regulatory partner. This new approach transforms regulatory compliance from a regional hurdle into a global strategic advantage, enabling faster, more efficient expansion into multiple markets simultaneously. Case Study: Imagine your company spent two years and millions of dollars to secure a CE Mark for its new device. Your EU representative holds the paperwork. But when your board decides to pivot and enter the lucrative Brazilian market, you discover your representative's expertise ends at the EU border. You're now facing another year of delays and a six-figure bill for new consultants to start the entire process over again. Key Takeaways From This Episode: 1. Is your European Authorized Representative a strategic partner or just a legal necessity? 2. How can a "Single Process, Multiple Markets" approach cut your global registration time in half? 3. What are the risks of having your technical dossier managed by a non-specialized firm? 4. How can AI-driven tools prevent costly errors and delays in your regulatory submissions? 5. Why is integrated post-market surveillance crucial for maintaining global market access? 6. Are you leveraging your existing regulatory approvals to their full potential for global expansion? 7. What key questions should you ask when vetting a potential regulatory partner versus a simple representative? To learn more, contact us at info@pureglobal.com or visit https://pureglobal.com/.
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    3 分
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