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The QA Files Podcasts

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Medical Device Global Market Access

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 ...
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The New Meta

New Meta Podcast

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This is a an ARPG focused podcast featuring Twitch Streamers Lord_Fluffy and ThaPchild. Stay tuned for the latest news and discussions on all things ARPG’s including: Diablo 3, Diablo 4, PoE, PoE 2, Lost Ark, Last Epoch & many more!
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Game Industry Career Guide Podcast

Jason W. Bay

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Professional advice, information and inspiration on getting a job making video games. I’m Jason, your career mentor at Game Industry Career Guide. I’ve spent over 15 years in the game industry, doing lots of different jobs: QA Tester, 3D Modeler, Game Designer, Lead Programmer, Studio Technical Director, Director of Studio Operations, and General Purpose Entrepreneur. (Whew!) I’ve got years of experience hiring and managing game people from many backgrounds. I’ve also written for industry ma ...
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CE Marking: The Golden Key for Global MedTech Entry 4:40

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CE marking is a crucial certification for medical devices, acting as a legal key to the European market and a global benchmark for safety and quality. It signifies compliance with strict EU regulations (MDR/IVDR), offers competitive advantages, and provides a solid foundation for other international regulatory approvals, making it essential for man…
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Decoding High-Risk Medical Device Classifications Worldwide 3:29

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This episode unpacks the significant variations in "Class III" and "Class IV" medical device classifications across key global markets like the US, EU, Canada, China, and Saudi Arabia. We explore why a device's risk class in one country doesn't automatically apply elsewhere and what this means for manufacturers seeking international market access.K…
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2025 MedTech Fast Track: FDA Breakthroughs & CMS Coverage Acceleration 5:41

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This episode unpacks the 2025 landscape for the FDA's Breakthrough Devices Program and the transformative new CMS Transitional Coverage for Emerging Technologies (TCET) pathway. We explore how these initiatives are accelerating device clearance and Medicare coverage, including the impact of over 1,000 Breakthrough designations granted by September …
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Unlocking Global Markets: SaMD, AI, and Regulatory Fast-Tracks 4:34

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This episode provides a comprehensive guide to navigating the complex global regulatory landscape for Software as a Medical Device (SaMD), with a special focus on AI-enabled technologies. We explore SaMD risk classifications in key markets like the US, EU, and Canada, discuss recent AI-specific guidance from bodies like the FDA (including the Decem…
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China's 2025 MedTech Surge: NMPA's New Fast-Track for Innovative Devices 5:07

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This episode delves into China's transformative 2025 NMPA Roadmap, detailing how the "NMPA regulation 2025" aims to accelerate approvals for innovative medical devices. We explore the new Special Review Pathway, shortened clinical trial timelines, priority review categories, and expanded domestic production opportunities, offering insights for manu…
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Saudi MedTech Breakthrough: Understanding the SFDA's MDS-G002 Pathway 3:55

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This episode delves into the Saudi Food and Drug Authority’s (SFDA) Innovative Medical Devices Pathway (MDS-G002), a strategic initiative designed to significantly accelerate market entry for novel medical technologies in Saudi Arabia. We explore the key features, eligibility criteria, and the profound impact this pathway has on reducing time-to-ma…
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Brazil's RDC 751/2022: Your 2025 MedTech Compliance Guide 3:21

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This episode unpacks Brazil's transformative RDC 751/2022 medical device regulation, effective since March 1, 2023. We cover the updated four-tier risk classification system, the 22 detailed classification rules (including those for SaMD and nanomaterials) aligning with EU MDR, and the distinct Notification (Class I/II) versus Registration (Class I…
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FDA's Landmark QMSR Rule: ISO 13485 Harmonization for 2026 3:31

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This episode delves into the U.S. FDA's significant 2024 Quality Management System Regulation (QMSR) final rule. We explore how this rule, effective February 2, 2026, aligns 21 CFR Part 820 with the international standard ISO 13485:2016, discuss key changes, FDA-specific additions, and the crucial steps medical device manufacturers must take to pre…
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EU MDR's New Timetable: Are You Ready for 2025, 2027, and 2028? 4:50

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This episode delves into the crucial extended transition deadlines for the EU Medical Device Regulation (EU MDR), now set for 2027 and 2028. We explore what these extensions mean for manufacturers of legacy medical devices, emphasizing the critical actions that should have been completed by May and September 2024 to benefit from this extra time. Th…
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EU IVDR: Strengthening Your MedTech Supply Chain Controls 4:43

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This episode delves into the critical supply chain requirements for Economic Operators under the EU's In Vitro Diagnostic Regulation (IVDR), referencing insights from April 14, 2025. We explore common pitfalls leading to Notified Body non-conformities, the specific obligations for manufacturers, importers, distributors, and authorized representativ…
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Unlocking Worldwide IVD Access with Europe's IVDR 4:03

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This episode explores how the European Union's stringent In Vitro Diagnostic Devices Regulation (IVDR) can strategically benefit IVD manufacturers seeking market access beyond the EU. We discuss leveraging IVDR CE Marking for easier entry into global markets, the role of harmonized quality management systems like ISO 13485, and the importance of a …
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Leveraging Real-World Data: MHRA's Blueprint for Clinical Trials 4:33

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This episode delves into the UK's Medicines and Healthcare products Regulatory Agency (MHRA) guidance, updated 20 May 2025, on utilizing Real-World Data (RWD) in randomised controlled trials for regulatory decisions. We explore the scope, design considerations, safety monitoring, and regulatory acceptability of RWD-based trials, highlighting their …
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Navigating MHRA's 2025 Real-World Data Guidance for UK Clinical Trials 4:03

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This episode unpacks the UK MHRA's updated May 20, 2025, guidance on employing Real-World Data (RWD) in clinical studies for regulatory approval. We discuss the scope, the critical emphasis on data quality, essential considerations for sponsors using RWD sources like EHRs and wearables, and how the MHRA is shaping the future of evidence generation …
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Wireless MedTech: Navigating Global RF Compliance 5:19

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This episode offers medical device manufacturers an essential overview of navigating global wireless compliance when integrating radio frequency (RF) modules. We explore crucial considerations from selecting RF module suppliers and understanding international certification pathways—like modular versus system-level approvals—to compiling necessary d…
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Brazil's MedTech Pulse: Fresh Registration Insights for 2025 Q2 5:10

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This episode delves into the latest medical device registration data from Brazil, focusing on trends observed in March and April 2025. We explore the prevalence of Class I and II devices, particularly in diagnostics, the types of higher-risk Class IV devices gaining approval, and the manufacturing landscape, highlighting both strong domestic produc…
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