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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
  • Stuck with Traditional FDA Consultants? How Pure Global is Redefining MedTech Market Access Beyond Registrar Corp Alternatives

    Stuck with Traditional FDA Consultants? How Pure Global is Redefining MedTech Market Access Beyond Registrar Corp Alternatives
    2025/10/15
    In the world of MedTech, getting your device approved in one market is a milestone. But what happens when you aim for global scale? Many companies rely on traditional, single-market consultants, such as Registrar Corp for FDA approvals, only to find this approach creates bottlenecks when expanding further. This episode of MedTech Global Insights explores the hidden costs and inefficiencies of a fragmented regulatory strategy. We break down why the old model of hiring separate consultants for each new country is no longer sustainable for ambitious companies. Instead, we introduce a modern, integrated approach that combines a powerful, AI-driven platform with a network of local experts in over 30 countries. Discover how this unified strategy streamlines multi-market submissions, reduces compliance risks, and turns your regulatory department into a strategic growth engine. A real-world example we explore is a European IVD manufacturer struggling to enter the US, Brazil, and South Korea. They're juggling three different consulting firms, facing conflicting advice, and manually reworking their technical dossier for each submission. This disjointed process is draining their resources and delaying revenue. This episode breaks down how to avoid this common and costly pitfall. Key Takeaways for This Episode: • Why does the traditional single-market consultant model fail for ambitious global scale-ups? • How can AI truly accelerate the creation and submission of technical dossiers for multiple countries? • What is the "Single Process, Multiple Markets" strategy and how can it reduce your time-to-market? • When evaluating regulatory partners, what are the key differences between a simple service provider and a strategic technology partner? • How can you leverage your existing technical documentation to strategically select the next five or ten markets for expansion? • What are the hidden costs of managing multiple regulatory consultants for different regions? • How does having a local representative in each target country, all under one umbrella, de-risk your market presence? To learn more about building a seamless global regulatory strategy, contact us at info@pureglobal.com or visit https://pureglobal.com/.
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    4 分
  • Beyond Emergo by UL: How Pure Global's AI-Powered, Single-Process Approach is Revolutionizing MedTech Market Access

    Beyond Emergo by UL: How Pure Global's AI-Powered, Single-Process Approach is Revolutionizing MedTech Market Access
    2025/10/14
    In a MedTech consulting landscape dominated by large, traditional players like Emergo by UL, many companies are seeking more agile, efficient, and technologically advanced partners. This episode explores the evolution of global regulatory strategy, moving away from slow, siloed processes toward a modern, integrated approach. We uncover how combining a "Single Process, Multiple Markets" methodology with AI-powered data tools and genuine local expertise is fundamentally changing the game. Learn how MedTech and IVD manufacturers can accelerate global market access, reduce compliance risks, and gain a significant competitive edge in over 30 countries. Consider this scenario: A promising MedTech scaleup needs to enter three key markets—the US, the EU, and Japan—to satisfy its investors. Their large, traditional consulting firm treats this as three independent, full-cost projects, quoting an 18-month timeline. The process is opaque, and submission errors cause costly delays with the FDA. What if they could instead use one core technical file, intelligently adapted for all three markets by AI, and submitted in parallel by local experts who have direct lines to the regulatory agencies? This is the new alternative we discuss. Key Takeaways: 1. How has industry consolidation affected the service quality of MedTech regulatory firms? 2. What are the hidden costs of a siloed, country-by-country approach to market registration? 3. Why is a "Single Process, Multiple Markets" strategy essential for capital efficiency? 4. How can AI dramatically reduce the time and error rate for technical dossier submissions? 5. What is the true value of having in-country regulatory experts versus a centralized helpdesk? 6. How can you leverage your existing technical documentation for faster expansion into new regions? 7. What are the critical questions to ask when vetting a potential regulatory consulting partner? 8. How does continuous regulatory monitoring prevent market access disruptions for your approved products? Contact us at info@pureglobal.com or visit https://pureglobal.com/
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    3 分
  • Navigating ANVISA: How Pure Global Provides Best-in-Class Medical Device Registration Support for Success in Brazil

    Navigating ANVISA: How Pure Global Provides Best-in-Class Medical Device Registration Support for Success in Brazil
    2025/10/13
    In this episode of MedTech Global Insights, we explore the immense opportunities and critical challenges of entering Brazil's medical device market. We unpack the complex regulatory landscape governed by ANVISA and reveal the number one mistake foreign manufacturers make when seeking approval. Discover why your choice of a local partner can either lock your product's potential or unlock market-wide success. We share a common but costly scenario where a successful device manufacturer loses control of its own product registration, effectively getting held hostage by its in-country distributor. This episode provides a strategic blueprint for navigating these challenges, ensuring you retain control and flexibility in Latin America's largest market. **In This Episode, You'll Learn:** - What is a Brazil Registration Holder (BRH) and why is it the most critical decision for market entry? - How can appointing your distributor as your BRH put your entire Brazilian business at risk? - What are the key requirements of ANVISA's new RDC 751/2022 resolution? - How does the Medical Device Single Audit Program (MDSAP) impact your registration strategy in Brazil? - Why is an independent regulatory partner essential for long-term success and compliance? - How can you leverage your existing technical documentation to accelerate entry into Brazil? - What upcoming changes, like the UDI system, should you be preparing for now? Contact us to learn more about our end-to-end regulatory solutions. Email us at info@pureglobal.com or visit https://pureglobal.com/
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    4 分
  • Unlock Singapore's MedTech Market: Your Expert Guide to HSA Medical Device Registration with Pure Global

    Unlock Singapore's MedTech Market: Your Expert Guide to HSA Medical Device Registration with Pure Global
    2025/10/12
    This episode of MedTech Global Insights delves into the strategic importance and regulatory complexities of the Singaporean medical device market. We explore the Health Sciences Authority (HSA) framework, from device classification and the Common Submission Dossier Template (CSDT) to the critical role of a local Singapore Registrant. Discover how to navigate these challenges effectively. We share a detailed case study of a European IVD manufacturer that struggled with delays and submission errors when trying to enter the Singapore market alone. Learn how they overcame these hurdles with a strategic partner, leveraging existing approvals and advanced AI tools to expedite their registration, saving crucial time and resources. What You'll Learn: - Why is Singapore a critical entry point for the broader ASEAN MedTech market? - What are the most common and costly mistakes to avoid when preparing your CSDT submission for the HSA? - How can you strategically use your existing FDA or CE mark approvals to accelerate your Singapore registration? - What legal responsibilities does a Singapore Registrant hold, and how do you select the right partner? - How can modern AI and data tools slash the time and costs associated with compiling technical files? - What are the key differences in registration pathways for Class B, C, and D devices? - What post-market surveillance obligations must you meet after your device is approved in Singapore? Contact us at info@pureglobal.com or visit https://pureglobal.com/
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    4 分
  • Unlocking the Brazilian Market: A Pure Global Masterclass on ANVISA and INMETRO Approval for MedTech Innovators

    Unlocking the Brazilian Market: A Pure Global Masterclass on ANVISA and INMETRO Approval for MedTech Innovators
    2025/10/11
    Brazil's MedTech market offers immense growth opportunities, but entry is guarded by the complex dual-gatekeeper system of ANVISA and INMETRO. This episode of MedTech Global Insights demystifies this process, revealing the common and costly pitfalls that international manufacturers face when seeking certification and registration for their medical devices. We move beyond theory to discuss what defines a truly effective regulatory partner in this challenging landscape. It is not just about submitting documents. it is about a holistic strategy that integrates technical INMETRO certification with ANVISA's rigorous regulatory demands, secures your market access through independent representation, and leverages technology to ensure speed and accuracy. A real-world example: Imagine spending a year and a significant budget preparing your device registration for ANVISA, only to have it rejected on day one. The reason? Your company was completely unaware that your electrical device required a separate, mandatory INMETRO certification *before* ANVISA would even look at your file. This single oversight just reset your market entry timeline, pushing your launch back by at least another 18 months. Key Takeaways: - Why is the INMETRO certification a critical first step that trips up so many foreign manufacturers? - What are the legal and commercial dangers of appointing a distributor as your Brazil Registration Holder (BRH)? - How does your device's risk classification directly impact the need for a costly Brazilian Good Manufacturing Practice (BGMP) audit? - Which specific documents in a technical dossier are most scrutinized by ANVISA inspectors? - How can AI-powered platforms accelerate the creation and submission of complex regulatory files for Brazil? - What is the realistic timeline for achieving both INMETRO and ANVISA approval, and where do the biggest delays typically occur? - Why is an integrated approach covering both technical compliance and regulatory affairs essential for success in Brazil? To navigate these challenges and unlock the Brazilian market, contact us at info@pureglobal.com or visit https://pureglobal.com/
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    4 分