『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
無料で聴く

このコンテンツについて

 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
  • Brazil's RDC 751/2022: Your 2025 MedTech Compliance Guide

    Brazil's RDC 751/2022: Your 2025 MedTech Compliance Guide
    2025/06/01
    This episode unpacks Brazil's transformative RDC 751/2022 medical device regulation, effective since March 1, 2023. We cover the updated four-tier risk classification system, the 22 detailed classification rules (including those for SaMD and nanomaterials) aligning with EU MDR, and the distinct Notification (Class I/II) versus Registration (Class III/IV) pathways. Exporters will receive essential compliance tips for 2025, focusing on re-classification, technical documentation, labeling in Brazilian Portuguese, B-GMP, and e-labeling provisions to successfully navigate the Brazilian market. Key Questions: • What are the four risk classes under Brazil's RDC 751/2022? • How do the 22 new classification rules impact your medical device? • What are the key differences between Notification and Registration pathways in Brazil? • Have you updated your device classification and documentation since March 1, 2023? • What are the specific requirements for SaMD and nanomaterials under the new Brazilian rules? • What are the crucial labeling and IFU changes, including language requirements? • Is your B-GMP certification compliant for Brazilian market access? • How can you leverage e-labeling options under RDC 751/2022? 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.
    続きを読む 一部表示
    3 分
  • FDA's Landmark QMSR Rule: ISO 13485 Harmonization for 2026

    FDA's Landmark QMSR Rule: ISO 13485 Harmonization for 2026
    2025/05/31
    This episode delves into the U.S. FDA's significant 2024 Quality Management System Regulation (QMSR) final rule. We explore how this rule, effective February 2, 2026, aligns 21 CFR Part 820 with the international standard ISO 13485:2016, discuss key changes, FDA-specific additions, and the crucial steps medical device manufacturers must take to prepare for this transition. Key Questions: • What is the FDA's new Quality Management System Regulation (QMSR) issued on January 31, 2024? • How does the QMSR integrate ISO 13485:2016 into U.S. medical device regulations? • When is the critical effective date for the new QMSR requirements? • What are the main differences between the outgoing Quality System Regulation (QSR) and the incoming QMSR? • Beyond ISO 13485, what supplemental FDA-specific requirements must manufacturers address? • How will FDA inspections adapt to the new QMSR framework? • What actions should manufacturers prioritize during the two-year transition period ending February 2, 2026? • Is achieving ISO 13485 certification sufficient for QMSR compliance? 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.
    続きを読む 一部表示
    4 分
  • EU MDR's New Timetable: Are You Ready for 2025, 2027, and 2028?

    EU MDR's New Timetable: Are You Ready for 2025, 2027, and 2028?
    2025/05/30
    This episode delves into the crucial extended transition deadlines for the EU Medical Device Regulation (EU MDR), now set for 2027 and 2028. We explore what these extensions mean for manufacturers of legacy medical devices, emphasizing the critical actions that should have been completed by May and September 2024 to benefit from this extra time. The focus for 2025 shifts from new extension-specific filings to the continuous maintenance of an MDR-compliant Quality Management System, robust post-market surveillance, and up-to-date technical documentation, ensuring devices remain safe and that manufacturers are audit-ready. Key Questions: • What are the new EU MDR compliance deadlines for 2027 and 2028? • Did your company meet the critical May 26, 2024, application deadline? • Was a signed agreement with a Notified Body in place by September 26, 2024? • What does "maintaining compliance" truly mean for legacy devices in 2025? • Are there new EU MDR filings required in 2025 for the extension? • How does post-market surveillance change for legacy devices under these extensions? • What happens if significant changes are made to a legacy device? • What are the consequences of not meeting the 2024 prerequisites? • How can manufacturers ensure their QMS remains MDR-compliant throughout 2025? 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.
    続きを読む 一部表示
    5 分

Medical Device Global Market Accessに寄せられたリスナーの声

カスタマーレビュー：以下のタブを選択することで、他のサイトのレビューをご覧になれます。

Audible.co.jp

Amazon.co.jp
レビューはまだありません。