Episodes

  • Unlocking Global Markets with the New Health Software Security Standard

    Unlocking Global Markets with the New Health Software Security Standard
    Aug 2 2025
    This episode delves into the critical cybersecurity standard IEC 81001-5-1, published in 2021. We explore its origins, its comprehensive lifecycle approach to securing health software, and its growing importance for regulatory approval in key global markets like the EU, US, and Japan. Manufacturers will learn what the standard requires and why compliance is no longer optional but a strategic advantage. Key Questions: • What is IEC 81001-5-1 and why was it created? • How does this standard change the approach to software development and maintenance? • Does this standard apply only to medical devices, or is the scope broader? • What are the core requirements, from threat modeling to post-market surveillance? • How does the standard build upon existing frameworks like IEC 62304? • What is the regulatory status of IEC 81001-5-1 in the EU and the US? • Why is compliance becoming a non-negotiable for global market access? • What are the risks of ignoring this new cybersecurity benchmark? 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 mins
  • One Audit, Five Markets: Unlocking Global Access with MDSAP

    One Audit, Five Markets: Unlocking Global Access with MDSAP
    Aug 1 2025
    This episode demystifies the Medical Device Single Audit Program (MDSAP), a framework allowing a single audit to satisfy the regulatory requirements of five different countries. We explore its history, the participating authorities, the benefits for manufacturers—including reduced audit fatigue and faster market access—and how the program streamlines global compliance. • What is the Medical Device Single Audit Program (MDSAP)? • Which five major global markets can you access with a single audit? • How does MDSAP reduce audit fatigue and save resources for manufacturers? • What makes MDSAP a mandatory requirement for selling medical devices in Canada? • How can one audit report substitute for a routine FDA inspection? • What is the role of an Auditing Organization (AO) in the MDSAP process? • Which international body initiated the MDSAP program in 2012? 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 mins
  • From FDA Clearance to TGA Inclusion: Navigating the Australian Medical Device Market

    From FDA Clearance to TGA Inclusion: Navigating the Australian Medical Device Market
    Jul 31 2025
    This episode details the specific steps and documentation required to list an FDA-cleared medical device on Australia's Australian Register of Therapeutic Goods (ARTG). We explore how leveraging your existing FDA approval can streamline the TGA inclusion process, the critical role of an Australian Sponsor, and the importance of recent regulatory updates effective in late 2024. • Is my FDA clearance automatically accepted in Australia? • What is the very first step for a foreign manufacturer to enter the Australian market? • Which specific FDA documents does the TGA accept as evidence? • What is an Australian Declaration of Conformity and is it required? • Do I need a new Quality Management System certificate for Australia? • How can I use my existing clinical data for the TGA application? • What is the key regulatory change happening on October 19, 2024? • What are my responsibilities after my device is listed on the ARTG? 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 mins
  • From FDA PMA to Health Canada: A Guide to Licensing High-Risk Medical Devices

    From FDA PMA to Health Canada: A Guide to Licensing High-Risk Medical Devices
    Jul 30 2025
    Holding FDA PMA approval is a significant achievement, but what does it mean for entering the Canadian market? This episode breaks down the essential steps and requirements for obtaining a Health Canada Medical Device Licence for your high-risk device. We explore how to leverage your existing FDA data while navigating Canada's unique regulatory landscape. • Does FDA PMA guarantee a Health Canada licence? • What are the Canadian device classifications for high-risk products? • Is an FDA-compliant QMS enough for Health Canada? • What is the Medical Device Single Audit Program (MDSAP) and why is it critical? • What is the difference between a Medical Device Licence (MDL) and a Medical Device Establishment Licence (MDEL)? • Can my FDA submission documents be used for a Health Canada application? • What specific formatting does Health Canada require for submissions? • Are there unique labelling requirements for the Canadian market? • How have regulations changed since the 2016 notice on using FDA guidance? 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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    4 mins
  • From FDA 510(k) to EU CE Mark: Bridging the Regulatory Gap

    From FDA 510(k) to EU CE Mark: Bridging the Regulatory Gap
    Jul 29 2025
    Think your FDA 510(k) is a fast track to a European CE Mark? This episode uncovers the critical gaps between the two regulatory systems. We explore the fundamental differences in philosophy, from the FDA's "substantial equivalence" model to the EU MDR's lifecycle approach, and detail the extra work required in quality management, clinical evidence, technical documentation, and post-market surveillance to achieve compliance in Europe. Key Questions: • Is a 510(k) clearance a shortcut to getting an EU MDR CE Mark? • How do the Quality Management System (QMS) requirements for the FDA and EU differ? • Why isn't the data for my 510(k) enough for a European Clinical Evaluation Report (CER)? • What are the General Safety and Performance Requirements (GSPRs) and why are they crucial for my EU Technical File? • How does the EU's proactive Post-Market Surveillance (PMS) system compare to the FDA's requirements? • What is a Notified Body, and why is their pre-market audit essential for European market access? • What is a Periodic Safety Update Report (PSUR) and will my device require one? 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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    4 mins
  • Leveraging Your FDA De Novo for Brazilian Market Access

    Leveraging Your FDA De Novo for Brazilian Market Access
    Jul 28 2025
    This episode breaks down how to leverage an FDA De Novo grant to achieve medical device registration in Brazil with ANVISA. We explain that while the De Novo is a powerful asset, it does not grant automatic approval. We cover the essential steps, from determining your device's risk classification under Brazilian regulations to understanding the different registration pathways (*Notificação* vs. *Registro*), the mandatory requirement of a Brazil Registration Holder (BRH), and the importance of compiling a technical dossier using your existing FDA data. • Does an FDA De Novo grant guarantee ANVISA approval in Brazil? • What is the most critical first step when seeking Brazilian market access? • How does Brazil's risk classification system differ from the FDA's? • What is the difference between the *Notificação* and *Registro* pathways? • Is it possible to register a device in Brazil without a local office? • What is a Brazil Registration Holder (BRH) and why are they essential? • How can the data from my De Novo submission accelerate ANVISA registration? • What are INMETRO and ANATEL certifications, and does my device need them? 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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    4 mins
  • Beyond FDA Clearance: A Guide to China's NMPA Medical Device Registration

    Beyond FDA Clearance: A Guide to China's NMPA Medical Device Registration
    Jul 27 2025
    This episode demystifies the process for registering an FDA-cleared medical device in China. We explore why FDA approval is only the first step and detail the unique requirements of the National Medical Products Administration (NMPA), including classification, local agent representation, in-country testing, and clinical data validation for the Chinese market. Key Questions: • Is my US FDA clearance sufficient for selling my device in China? • What is an NMPA Legal Agent and why do I need one? • Does my device's risk classification change between the FDA and NMPA? • Will I need to conduct new device testing in a Chinese lab? • Can I use my existing clinical trial data for the NMPA submission? • What is a Product Technical Requirement (PTR) and how is it used? • What are the main challenges when submitting a technical dossier to the NMPA? • How did the October 1, 2021, NMPA provisions change the regulatory landscape? 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 mins
  • Beyond the Lab: Mastering Clinical Trials with ISO 14155:2020

    Beyond the Lab: Mastering Clinical Trials with ISO 14155:2020
    Jul 26 2025
    This episode provides a detailed overview of ISO 14155:2020, the international standard for Good Clinical Practice in medical device investigations. We explore the key updates from the previous version, focusing on the integration of risk management, new planning requirements, and operational changes that impact how manufacturers design and conduct clinical trials. Learn what your team needs to know to ensure compliance and generate robust clinical data for global regulatory submissions. Key Questions: • What is the fundamental purpose of ISO 14155:2020 in medical device development? • How has the role of risk management (ISO 14971) been expanded in the latest version? • What are the new, more stringent requirements for a Clinical Investigation Plan (CIP)? • How does the standard align with major regulations like the EU MDR? • What is risk-based monitoring and how does it affect study conduct? • Are there new guidelines for ethics committees and clinical audits? • Why is public registration of a clinical trial now a critical step? • What does "clinical quality management" mean under ISO 14155:2020? 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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    4 mins