Medical Device Global Market Access cover art

Medical Device Global Market Access

Medical Device Global Market Access

By: Pure Global
Listen for free

About this listen

 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
Episodes
  • Decoding MedTech Regulations: QMSR, ISO 13485 & Global Strategy

    Decoding MedTech Regulations: QMSR, ISO 13485 & Global Strategy
    Jun 17 2025
    This episode unpacks the evolving world of medical device regulatory compliance. We explore crucial updates, including the FDA's QMSR Final Rule effective February 2026 and its alignment with ISO 13485:2016. We also cover diverse global frameworks, core compliance components like QMS and risk management, common challenges, and strategic approaches to ensure market success while prioritizing patient safety. Key Questions: • What is the significance of the FDA’s QMSR Final Rule for medical device manufacturers? • How does the QMSR align U.S. regulations with the international ISO 13485:2016 standard? • When will the FDA's QMSR Final Rule become effective? • What are the key differences in regulatory requirements between the US, EU, Japan, and other major markets? • What constitutes a robust Quality Management System (QMS) for medical devices? • How can manufacturers effectively manage risks according to ISO 14971? • What are the primary challenges in achieving and maintaining global medical device compliance? • What strategies can MedTech companies employ for proactive regulatory 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.
    Show More Show Less
    4 mins
  • Wearable Health: Revolutionizing Patient Care and Monitoring

    Wearable Health: Revolutionizing Patient Care and Monitoring
    Jun 16 2025
    This episode explores the dynamic field of wearable medical devices. The host discusses the various types, from smartwatches to specialized sensors, their key functions in monitoring, screening, detection, and prediction, and the significant benefits they offer for patient empowerment, remote care, and chronic disease management. The discussion also covers critical challenges like data accuracy, privacy, and system integration, while looking towards future advancements driven by AI and IoMT. Key Questions: • What are wearable medical devices and how are they revolutionizing healthcare? • Beyond fitness tracking, what advanced medical monitoring can today's wearables perform? • How do these devices empower patients and facilitate remote and preventive care? • What are the primary hurdles, such as data privacy and accuracy, in the adoption of medical wearables? • How will artificial intelligence and the Internet of Medical Things shape the next generation of wearable health technology? • What steps are needed to ensure equitable access and reliable performance of wearables across diverse populations? • Can smart rings and clothing truly provide clinically relevant health insights? 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.
    Show More Show Less
    4 mins
  • 2024-2025 MedTech Frontier: Devices Changing Patient Care

    2024-2025 MedTech Frontier: Devices Changing Patient Care
    Jun 15 2025
    This episode explores the cutting-edge medical device technologies set to revolutionize healthcare in 2024 and 2025. We delve into advancements in noninvasive wearables, home care systems, surgical tools, AI-driven diagnostics, and specialized treatments for cardiovascular, orthopedic, and neurological conditions, highlighting how these innovations are paving the way for more personalized, efficient, and patient-centric care. Key Questions: • What are the most exciting wearable health monitors emerging in 2024-2025? • How are new devices making complex treatments like dialysis accessible at home? • What role is AI playing in the next generation of diagnostic and hearing technologies? • Are there new minimally invasive options for heart conditions and pediatric care recently approved or in development for 2024-2025? • How is real-time imaging, like the Lumicell DVS approved in 2024, changing cancer surgery outcomes? • What innovations are helping patients manage chronic conditions like diabetes and essential tremor more effectively in 2024? • Which new devices from 2024 are improving surgical precision and recovery? 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.
    Show More Show Less
    5 mins

What listeners say about Medical Device Global Market Access

Average Customer Ratings

Reviews - Please select the tabs below to change the source of reviews.

Audible.com.au reviews

Amazon Reviews
No Reviews are Available
In the spirit of reconciliation, Audible acknowledges the Traditional Custodians of country throughout Australia and their connections to land, sea and community. We pay our respect to their elders past and present and extend that respect to all Aboriginal and Torres Strait Islander peoples today.