『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 2026 Pure Global
エピソード
  • Korean MedTech in Brazil: Navigating ANVISA's B-GMP Certification

    Korean MedTech in Brazil: Navigating ANVISA's B-GMP Certification
    2026/01/10
    This episode unpacks the most critical step for Korean medical device companies entering the Brazilian market: ANVISA's Brazilian GMP (B-GMP) certification. We detail the mandatory B-GMP requirements for Class III and IV devices and compare the two main compliance pathways. Discover the significant time and cost advantages of leveraging MDSAP certification, which can extend certificate validity to four years and potentially waive on-site inspections, versus the timeline and costs associated with a direct ANVISA audit at your Korean facility. We also explain how to use your existing K-GMP certification as a strong foundation for B-GMP readiness. - What is B-GMP and why is it essential for selling high-risk medical devices in Brazil? - How can MDSAP certification streamline the ANVISA approval process for Korean manufacturers? - What are the potential time and cost savings of using the MDSAP pathway for B-GMP? - What does the B-GMP process look like for companies without MDSAP certification? - How long does a direct ANVISA on-site audit in Korea typically take? - Can my existing K-GMP certification help me achieve B-GMP compliance? - What is the validity period for a B-GMP certificate obtained through MDSAP versus a direct audit? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access. We act as your local representative in over 30 markets, including Brazil, developing efficient regulatory strategies and using advanced AI to compile technical dossiers. Our integrated approach allows a single registration process to access multiple markets. Whether you're a startup or a multinational, we help you navigate complex requirements like ANVISA's B-GMP. Visit us at https://pureglobal.com, email info@pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai to accelerate your market entry.
    続きを読む 一部表示
    3 分
  • Korean MedTech in Brazil: Unlocking ANVISA Approval with a Brazilian Registration Holder (BRH)

    Korean MedTech in Brazil: Unlocking ANVISA Approval with a Brazilian Registration Holder (BRH)
    2026/01/09
    This episode explores the single most critical regulatory requirement for Korean medical device companies entering the Brazilian market: the mandatory appointment of a Brazilian Registration Holder (BRH). We delve into why foreign companies cannot register directly with ANVISA, contrast Brazil's system with Korea's MFDS, and outline the extensive legal and operational responsibilities of a BRH, from registration and GMP inspections to post-market surveillance. Learn why selecting the right local partner is essential for your success in Brazil. Key Questions: - What is a Brazilian Registration Holder (BRH) and why is it mandatory for market entry? - How does Brazil's ANVISA registration process differ from Korea's MFDS system for foreign manufacturers? - Can a Korean medical device company register its product in Brazil without a local representative? - What are the key legal responsibilities of a BRH in Brazil? - How does the BRH manage GMP inspections and post-market surveillance? - Why is cultural and regulatory understanding crucial when selecting a BRH partner? - What are the risks of choosing the wrong local representative in Brazil? Navigating complex markets like Brazil requires expert local knowledge. Pure Global provides end-to-end regulatory solutions for MedTech and IVD companies, acting as your local representative and Brazilian Registration Holder (BRH) to streamline market access. Our team of in-country experts, supported by advanced AI tools, manages everything from initial regulatory strategy and technical dossier submission to post-market surveillance. We bridge the gap between your company and ANVISA, ensuring a compliant and efficient path to market. Contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.
    続きを読む 一部表示
    3 分
  • EU MDR Clinical Investigations: Navigating Deadlines and Data Requirements for European Market Access

    EU MDR Clinical Investigations: Navigating Deadlines and Data Requirements for European Market Access
    2026/01/08
    This episode provides a detailed overview of the clinical investigation requirements under the European Union's Medical Device Regulation (MDR). We explore the critical distinctions between pre-market clinical investigations and post-market clinical follow-up (PMCF), the role of the Clinical Evaluation Report (CER) as a living document, and the key transitional deadlines that manufacturers of legacy devices must meet to maintain market access. We also touch on the function of the EUDAMED database in enhancing transparency. - What are the primary differences between clinical data requirements under the old MDD and the current MDR? - How does the MDR define a pre-market clinical investigation versus a post-market clinical follow-up (PMCF) study? - What were the critical compliance actions required by the May 26, 2024, deadline for legacy devices? - What is the significance of the September 26, 2024, deadline for agreements with Notified Bodies? - Why is the Clinical Evaluation Report (CER) now considered a living document that requires continuous updates? - What are the final transition deadlines for different device risk classes to become fully MDR compliant? - How will the EUDAMED database impact the transparency of clinical investigations in the EU? - What are the general requirements for reporting serious adverse events during a clinical investigation under the MDR? Navigating the EU MDR's stringent clinical evidence requirements demands deep regulatory expertise. Pure Global provides end-to-end consulting for MedTech and IVD companies, leveraging local experts and advanced AI to streamline global market access. We develop efficient regulatory strategies, use AI to compile technical dossiers, and act as your local representative to ensure you meet all pre-market and post-market obligations. To learn how we can accelerate your entry into over 30 global markets, visit us at https://pureglobal.com/, contact info@pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.
    続きを読む 一部表示
    4 分
まだレビューはありません