『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
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  • From EC REP to EU REP: Decoding Critical Medical Device Symbol Changes

    From EC REP to EU REP: Decoding Critical Medical Device Symbol Changes
    2025/07/24
    This episode breaks down the essential updates from ISO 15223-1:2021 and its recent 2025 amendment. We explore the new symbols for medical devices, translations, and sterilization, and detail the critical shift from the 'EC REP' to the 'EU REP' symbol, explaining the reasons and the compliance timeline for manufacturers. Key Questions: • What is ISO 15223-1:2021 and why is it essential for medical device labeling? • Which new symbols were introduced in the latest version? • Why is the 'EC REP' symbol being replaced by 'EU REP'? • What is the official publication date of the amendment changing the authorized representative symbol? • Do you need to immediately relabel all your existing products? • What does 'harmonization' mean and how does it affect your compliance timeline? • How should manufacturers strategically plan for this transition? • What are the implications of the new 'MD' and 'Translation' symbols? 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 分
  • Unpacking IEC 60601-1 Edition 3.2: The New Standard for Electrical Safety

    Unpacking IEC 60601-1 Edition 3.2: The New Standard for Electrical Safety
    2025/07/23
    This episode breaks down the critical updates in IEC 60601-1 Edition 3.2, the mandatory electrical safety standard for medical devices. We cover the key changes from Amendment 2, including alignment with ISO 14971, the adoption of IEC 62368-1 for IT equipment, and refined requirements for Means of Protection (MOP), helping manufacturers understand the impact on new device submissions, particularly since the FDA's enforcement date of December 17, 2023. • What is the primary goal of IEC 60601-1 and its latest update, Edition 3.2? • When did the FDA officially mandate compliance with Edition 3.2 for new device submissions? • How does the new edition change the requirements for information technology equipment integrated into medical devices? • What are the key differences between Means of Operator Protection (MOOP) and Means of Patient Protection (MOPP)? • Are components like opto-couplers now subject to new, specific requirements? • How has the standard evolved to better align with risk management principles from ISO 14971? • What are the updated requirements for fire enclosures and temperature limits? • Does my existing risk management file need to be updated to comply with Edition 3.2? 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
  • The Golden Key: How ISO 13485 Unlocks Global MedTech Markets

    The Golden Key: How ISO 13485 Unlocks Global MedTech Markets
    2025/07/22
    This episode demystifies ISO 13485:2016, the internationally recognized standard for Quality Management Systems (QMS) in the medical device industry. We explore the standard's core requirements, the critical changes introduced in the 2016 revision, and why compliance is the essential key for any MedTech company aiming to achieve regulatory approval and unlock access to markets across the globe, from the EU to the United States. Key Questions • What is ISO 13485 and how does it differ from the more general ISO 9001? • What critical updates were introduced in the March 2016 revision of the standard? • Why is a risk-based approach now central to the entire medical device lifecycle? • How does ISO 13485 serve as a passport to major global markets? • Is ISO 13485 certification a mandatory legal requirement? • What is the Medical Device Single Audit Program (MDSAP) and what is its connection to ISO 13485? • How is the US FDA aligning its Quality System Regulation (QSR) with this international standard? • What are the essential components of a compliant QMS, from design controls to post-market surveillance? 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

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