『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
エピソード
  • EU IVDR: Strengthening Your MedTech Supply Chain Controls

    EU IVDR: Strengthening Your MedTech Supply Chain Controls
    2025/05/29
    This episode delves into the critical supply chain requirements for Economic Operators under the EU's In Vitro Diagnostic Regulation (IVDR), referencing insights from April 14, 2025. We explore common pitfalls leading to Notified Body non-conformities, the specific obligations for manufacturers, importers, distributors, and authorized representatives, and strategies for ensuring your quality agreements and operational controls meet the stringent IVDR demands for enhanced traceability and patient safety in the EU market. Key Questions: • What are the four types of Economic Operators under EU IVDR and their core responsibilities? • Why are robust supply chain controls crucial for IVDR compliance and avoiding non-conformities? • Have the obligations for Economic Operators truly changed since May 2022, even for legacy devices? • What are the most common mistakes manufacturers make when defining Economic Operator roles and agreements? • How does EN ISO 13485 relate to controlling outsourced Economic Operator activities under IVDR? • What impact do new labeling, registration, and EUDAMED requirements have on IVD supply chains? • How can you ensure your quality agreements are up-to-date with IVDR Article 10-16 obligations? • Why is an existing ISO 13485 certificate not a guaranteed pass for supply chain audits? 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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    5 分
  • Unlocking Worldwide IVD Access with Europe's IVDR

    Unlocking Worldwide IVD Access with Europe's IVDR
    2025/05/28
    This episode explores how the European Union's stringent In Vitro Diagnostic Devices Regulation (IVDR) can strategically benefit IVD manufacturers seeking market access beyond the EU. We discuss leveraging IVDR CE Marking for easier entry into global markets, the role of harmonized quality management systems like ISO 13485, and the importance of a proactive global market access strategy in light of evolving international regulations, including the US FDA's QMSR effective February 2, 2026, and UK acceptance of CE marks until June 30, 2030. Key Questions: • How can the demanding EU IVDR actually simplify global market entry for IVD devices? • What is the significance of ISO 13485 in achieving broader international compliance? • How will the US FDA's QMSR, effective February 2, 2026, impact manufacturers with EU IVDR certification? • Which non-EU countries might recognize or streamline approvals based on an IVDR CE Mark? • Why is IVDR compliance becoming critical as legacy devices lose acceptance globally? • What are the key components of a successful global market access strategy for IVDs? • How can regulatory intelligence help IVD companies navigate complex international markets? • What opportunities does IVDR CE Marking create for accessing markets in Asia, Africa, the Middle East, and Latin America? • How long will the UK continue to recognize CE marking for market access (until June 30, 2030)? 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 分
  • Leveraging Real-World Data: MHRA's Blueprint for Clinical Trials

    Leveraging Real-World Data: MHRA's Blueprint for Clinical Trials
    2025/05/27
    This episode delves into the UK's Medicines and Healthcare products Regulatory Agency (MHRA) guidance, updated 20 May 2025, on utilizing Real-World Data (RWD) in randomised controlled trials for regulatory decisions. We explore the scope, design considerations, safety monitoring, and regulatory acceptability of RWD-based trials, highlighting their potential to streamline drug development, particularly for label expansions and repurposing existing medicines. Key Questions: • What is the MHRA's latest stance on using Real-World Data in clinical trials as of May 2025? • How can RWD potentially reduce burdens and accelerate regulatory submissions for medicinal products? • What are the critical design elements for a successful RWD-based randomised controlled trial? • When might blinding be necessary in RWD studies, and why? • How does the MHRA view the evidentiary value of RWD trials compared to traditional RCTs? • What are "Type A" clinical trials, and how does this classification impact safety reporting requirements? • What are some of the most suitable scenarios for leveraging RWD in clinical investigations, such as drug repurposing? • Are there specific considerations for designing non-inferiority trials that use RWD sources? • How is the guidance expected to evolve concerning medical devices and RWD? • Where can sponsors obtain further advice from the MHRA on their specific RWD trial proposals? 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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    5 分

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