Medical Device Global Market Access

About Medical Device Global Market Access

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.

Publisher

Pure Global

Category

technology

Language

en

Explicit

No

First episode

23 May 2025

Latest episode

11 Oct 2026

Latest episodes

361 of 459 episodes have a transcript.

1. 

   11 Oct 2026TRANSCRIPT

   Australia TGA Proposes Greater Medical Device Transparency: What Sponsors Need to Know

   Industry experts discuss the Australian TGA's proposed medical device transparency changes, guiding sponsors on preparing for new data accessibility obligations.

2. 

   10 Oct 2026TRANSCRIPT

   UK MHRA AI Medical Device Rules: What the New Lifecycle Framework Means for Manufacturers

   Industry experts break down the UK's new lifecycle-based AI medical device framework and its implications for manufacturers navigating evolving regulatory requirements.

3. 

   9 Oct 2026TRANSCRIPT

   UK MHRA AI Medical Device Regulation: New Lifecycle Approach and AI Airlock Phase 3

   Host [Host Name] and Guest [Guest Name], a [Guest Credential], discuss the UK MHRA's new lifecycle approach to regulating AI medical devices and the opening of AI Airlock Phase 3.

Inside a recent episode

Australia TGA Proposes Greater Medical Device Transparency: What Sponsors Need to Know

Published 11 Oct 2026 · Transcript excerpt

[…] This is a critical development for any manufacturer with products on the Australian market or planning to enter it. The core of the TGA's proposal is to create a more transparent regulatory environment for medical devices. The consultation sought feedback on making a much wider range of information publicly available. This includes details about device approvals, such as summaries of the clinical evidence used to support a device's inclusion on the Australian Register of Therapeutic Goods, known as the ARTG. It also covers post-market information, like summaries of adverse event reports, information on recalls and other safety actions, and periodic safety update reports. […]

Reach and audience

Public platform figures. Ratings count people who left a rating, not total listeners.

Apple Podcasts (US)

5.0 / 5

1 ratings

Spotify

5.0 / 5

1 ratings

Contact Medical Device Global Market Access

Guest appearances

Books guests

Based on episode analysis; this does not confirm that the show is currently accepting guests.

Questions about Medical Device Global Market Access