Medical Device Global Market Access Podcast Por Pure Global arte de portada

Medical Device Global Market Access

Medical Device Global Market Access

De: 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
Episodios
  • EU IVDR: Navigating New Deadlines and Stricter Rules

    EU IVDR: Navigating New Deadlines and Stricter Rules
    Aug 18 2025
    The European Union's In Vitro Diagnostic Regulation (IVDR) has replaced the IVDD, introducing a stricter, risk-based classification system and increasing Notified Body oversight for most devices. This episode breaks down the fundamental changes, the expanded scope that now includes software and genetic tests, and the critical extended transition deadlines established in July 2024, providing manufacturers with a clear roadmap for compliance. • What is the EU IVDR and how does it differ from the previous IVDD? • What are the new risk classifications (A, B, C, D) for IVDs? • How has the role of Notified Bodies changed under the new regulation? • What are the latest extended transition deadlines for high, moderate, and low-risk IVDs? • Are all IVD devices eligible for these extended deadlines? • What are the specific conditions for a legacy device to qualify for the transition period? • How does the IVDR affect medical device software and companion diagnostics? • What happens if a manufacturer’s IVDD certificate expired before the new extension? 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 m
  • Navigating Canada's MedTech Market: A Guide to the CMDR

    Navigating Canada's MedTech Market: A Guide to the CMDR
    Aug 17 2025
    Canada's medical device market is a significant opportunity, but navigating its regulatory framework, the CMDR (SOR/98-282), is essential for market entry. This episode provides a comprehensive overview of the Canadian Medical Devices Regulations, from its risk-based classification system to licensing, quality management, and post-market surveillance obligations for manufacturers and importers. • What are the four risk classes for medical devices in Canada? • What is the difference between a Medical Device Licence (MDL) and a Medical Device Establishment Licence (MDEL)? • Which device classes require an MDL before being sold in Canada? • What is the mandatory Quality Management System standard for Class II, III, and IV devices? • How does the Medical Device Single Audit Program (MDSAP) fit into Canadian compliance? • What are the bilingual labelling requirements for devices sold to the public? • Who is responsible for mandatory incident reporting? • What are the key post-market surveillance activities required under the CMDR? 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 m
  • EU Clinical Trial Blueprint: Unpacking the MDCG 2024-3 Guidance

    EU Clinical Trial Blueprint: Unpacking the MDCG 2024-3 Guidance
    Aug 16 2025
    This episode dissects the critical MDCG 2024-3 guidance issued in March 2024, which outlines the European Union's expectations for a Clinical Investigation Plan (CIP). We explore how this document harmonizes the EU MDR and ISO 14155:2020, establishing the best-practice blueprint for planning medical device studies. We break down the essential components your CIP must include, from the benefit-risk analysis and statistical design to data management and safety reporting, to ensure a successful regulatory submission. Key Questions: • What is the MDCG 2024-3 guidance, and why is it crucial for MedTech manufacturers? • How does this document unify the requirements of the EU MDR and ISO 14155:2020? • What are the core sections your Clinical Investigation Plan must now feature? • How should you structure the benefit-risk analysis to meet regulatory expectations? • What are the new guidelines for detailing statistical methods and data management? • How does the guidance address modifications, deviations, and adverse event reporting? • Is your current approach to clinical investigations compliant with these latest EU standards? • What information is required to demonstrate the scientific validity of your study design? 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 m
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