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Medical Device Global Market Access

Medical Device Global Market Access

Pure Global
Date de sortie : 2025-09-01
© Copyright 2025 Pure Global
Medical Device Global Market Access - QR Code
LibreNew
107 épisodes
Audio
Écouter sur Apple Podcasts
LibreNew
107 épisodes
Audio
Écouter sur Apple Podcasts
Date de sortie : 2025-09-01
© Copyright 2025 Pure Global
L’épisode le plus récent
De Novo Submissions: Will Your CE Mark Data Pass FDA Scrutiny?

De Novo Submissions: Will Your CE Mark Data Pass FDA Scrutiny?

This episode explores how medical device manufacturers can effectively use their existing CE mark clinical data for an FDA De Novo submission for a novel technology. We delve into the FDA's expectations for foreign data, common gaps between EU and US re
Durée : 3:48
Lecture
This episode explores how medical device manufacturers can effectively use their existing CE mark clinical data for an FDA De Novo submission for a novel technology. We delve into the FDA's expectations for foreign data, common gaps between EU and US requirements, and the strategic importance of the Pre-Submission program to de-risk market entry.
• Can you directly use your CE mark clinical study for an FDA De Novo submission?
• What are the most common data gaps the FDA identifies in European studies?
• How does the FDA's view on patient demographics differ from European regulators?
• Why might the standard of care in your EU study be a problem for the FDA?
• Is a US-based clinical trial always necessary if you already have CE mark data?
• What is a "bridging study" and when might you need one?
• How can a Pre-Submission meeting with the FDA save you time and money?
• What key FDA guidance from April 2015 governs the use of foreign clinical data?
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.
Id. d’épisode : 1000724382756
GUID : d354715c-7e9c-4f1d-9790-5cc55d81a7a0
Date de publication : 1/9/2025 à 14:05:53

Description

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.
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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.

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