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Medical Device Global Market Access

Medical Device Global Market Access

By: 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
Episodes
  • UAE MedTech Market Entry: A Guide to Timelines and Costs

    UAE MedTech Market Entry: A Guide to Timelines and Costs
    Sep 23 2025
    This episode provides a detailed breakdown of the timelines and costs associated with registering a medical device in the United Arab Emirates. We explore the two main regulatory pathways, the specific government fees in AED, and the often-overlooked indirect costs like translation and notarization that manufacturers must budget for. We also break down the review timelines based on MOHAP’s risk classification system. Key Questions: • What is the first step for any manufacturer entering the UAE market? • How does the device risk class affect the MOHAP review timeline? • What are the specific government fees in Emirati Dirhams for device registration? • Are there different regulatory pathways for professional-use versus home-use devices? • What are the "hidden costs" that can impact your budget? • How long is a medical device registration certificate valid for in the UAE? • Who is the primary regulatory authority for medical devices in the UAE? 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 mins
  • Beyond the Sale: The Critical Role of MedTech Service and Logistics

    Beyond the Sale: The Critical Role of MedTech Service and Logistics
    Sep 22 2025
    A successful product launch goes far beyond the initial sale. For manufacturers of high-complexity analyzers and consumables, the true test of a distribution partner lies in their logistical prowess and service support infrastructure. This episode explores the essential, non-negotiable support functions that ensure your device not only reaches the customer but operates reliably to meet the demanding uptime requirements of modern clinical laboratories. Key Questions: • Does your distribution strategy account for the entire product lifecycle? • How vital is unbroken cold-chain logistics for your reagents and consumables? • What does on-site installation and performance validation truly entail for complex instruments? • Can your support network provide immediate, 24-hour technical assistance to a lab in crisis? • Is your distributor equipped with the warehousing and field-service engineers needed to guarantee nationwide uptime? • How quickly can you deliver critical replacement parts to any clinical lab? • Are you prepared to meet the stringent uptime and quality standards mandated by regulations like the Clinical Laboratory Improvement Amendments (CLIA) of 1988? 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 mins
  • Distributor Contracts: Your Performance Shield or a Risky Gamble?

    Distributor Contracts: Your Performance Shield or a Risky Gamble?
    Sep 22 2025
    This episode dives into the critical components of medical device distributor agreements that protect manufacturers from underperformance. We explore how to structure contracts with specific Key Performance Indicators (KPIs) and robust termination clauses, turning your agreement into a tool for accountability and market success, rather than a liability. • How can an exclusive distributor agreement backfire and trap your product? • What are the most effective KPIs to include beyond simple sales numbers? • Why should you define targets for marketing spend and demo placements? • What specific performance failures should trigger a termination clause? • How can you structure a termination clause that is both fair and firm? • What is a "cure period" and why is it essential for a healthy partnership? • How do you ensure your distributor's sales team is properly trained and certified? • What other triggers, like insolvency, should be included in your agreement? 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 mins
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