הפודקאסטים הטובים ביותר ב-The Qa Files (2025)

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South Asia's MedTech Surge: A Guide to Market Trends & Opportunities 3:24

לפני יום3:24

3:24

This episode provides a comprehensive overview of the South Asian medical device market, highlighting key growth drivers, market size projections, and regulatory trends. We explore the unique dynamics of countries like India, Pakistan, and Bangladesh, comparing the region's trajectory with that of Southeast Asia and identifying the most promising s…

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Unlocking Indonesia: Your MedTech Entry Strategy 3:23

לפני יומיים3:23

3:23

This episode delves into the critical factors for introducing medical devices to the Indonesian market. We cover the regulatory framework, including the role of the Ministry of Health and the necessity of a Local Authorized Representative. We also discuss device classification, licensing, extensive documentation requirements like ISO 13485 and CSDT…

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U.S. MedTech Marketing: Navigating FDA & FTC Rules 3:53

לפני 3 ימים3:53

3:53

This episode delves into the essential U.S. regulations governing medical device marketing and advertising. We explore the roles of the FDA and FTC, key requirements for truthful and substantiated claims, the prohibition of off-label promotion, and how device classification impacts oversight. Learn about navigating online advertising, social media …

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Unlocking Markets: Navigating Medical Device Certifications 5:38

לפני 4 ימים5:38

5:38

This episode provides a comprehensive overview of the critical certification requirements for medical devices across key global markets. We explore the significance of ISO 13485 for quality management, the process of obtaining CE marking for European Union access, and the various FDA pathways for the United States market, along with other country-s…

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EU Market Entry: Mastering CE Marking for Medical Devices 5:03

לפני 5 ימים5:03

5:03

This episode provides a comprehensive guide to CE Marking for medical devices, a mandatory certification for accessing the European Economic Area. We cover the essential requirements, including device classification, Quality Management Systems, technical documentation, conformity assessments by Notified Bodies, clinical evaluations, the role of the…

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Decoding FDA Medical Device Pathways 3:29

לפני 6 ימים3:29

3:29

This episode provides a comprehensive overview of the U.S. FDA's medical device approval process. We break down the three device risk classifications, detail the primary regulatory pathways including Premarket Notification (510(k)), Premarket Approval (PMA), De Novo, and Humanitarian Device Exemption (HDE). Listeners will also learn about the gener…

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Decoding MedTech Regulations: QMSR, ISO 13485 & Global Strategy 3:32

לפני 7 ימים3:32

3:32

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 …

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Wearable Health: Revolutionizing Patient Care and Monitoring 4:26

לפני 8 ימים4:26

4:26

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 als…

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2024-2025 MedTech Frontier: Devices Changing Patient Care 4:41

לפני 9 ימים4:41

4:41

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…

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Protect & Prosper: Insurance Essentials for US MedTech 3:05

לפני 10 ימים3:05

3:05

This episode delves into the critical role of insurance for medical device companies in the USA. We explore the two main facets: securing product liability insurance to mitigate operational and legal risks, and navigating the health insurance reimbursement landscape to ensure patient access and commercial viability. We cover key steps like FDA appr…

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Navigating US Health Data Privacy: Is Your Device HIPAA-Ready? 3:28

לפני 11 ימים3:28

3:28

This episode demystifies "HIPAA compliance" for medical devices. The host explores when manufacturers become subject to HIPAA, the essential administrative, physical, and technical safeguards for protecting patient health information (PHI), patient rights regarding their data, requirements for data sharing and Business Associate Agreements, and the…

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ISO 13485 Explained: Your Key to MedTech Compliance and Trust 4:25

לפני 12 ימים4:25

4:25

This episode demystifies ISO 13485 certification, explaining how it signifies a robust Quality Management System for medical device organizations. We explore the certification process, its broad applicability across the device lifecycle, the stringent requirements for risk management and regulatory compliance, and its crucial role in ensuring produ…

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Unlock Global MedTech Markets: Finding Your Ideal Distributors 5:08

לפני 13 ימים5:08

5:08

This episode delves into proven strategies for medical device companies to identify, vet, and secure local importers and distributors worldwide. We explore a multifaceted approach, combining digital tools, key industry events, professional networks, and crucial due diligence steps to help you effectively expand your product's global reach and navig…

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The Multi-Billion Dollar Diagnosis: Unpacking MedTech's Top Revenue Generator 4:00

לפני 14 ימים4:00

4:00

This episode delves into the dominant force in medical device revenue: In Vitro Diagnostics (IVDs). We uncover why IVDs consistently lead the global market, highlighting key drivers like early disease detection and the rise of chronic illnesses. We also explore the geographical strongholds, with a focus on the U.S. market's supremacy, and identify …

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Beyond EU Bottlenecks: MedTech's New Global Market Hotspots 4:18

לפני 15 ימים4:18

4:18

This episode explores the evolving global market entry strategies for medical devices. We discuss the significant regulatory hurdles in the EU due to MDR/IVDR, leading manufacturers to increasingly prioritize the U.S. market. We also delve into the burgeoning opportunities in high-growth emerging markets across Asia-Pacific and Latin America, offer…

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MedTech Goes Global: Top 3 Expansion Strategies 2:37

לפני 16 ימים2:37

2:37

This episode delves into the three essential pillars for medical device companies aiming to expand their reach from local to international markets. We discuss the critical nature of understanding diverse international regulatory landscapes and the role of harmonization efforts. We also explore the importance of in-depth market research, effective p…

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CE Marking: The Golden Key for Global MedTech Entry 4:40

לפני 17 ימים4:40

4:40

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

לפני 18 ימים3:29

3:29

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

לפני 19 ימים5:41

5:41

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

לפני 20 ימים4:34

4:34

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

לפני 21 ימים5:07

5:07

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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Episode 101: A Trailer 17:48

לפני 22 ימים17:48

17:48

Some things to consider, QA. A Trailer.על ידי The QA Files

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Saudi MedTech Breakthrough: Understanding the SFDA's MDS-G002 Pathway 3:55

לפני 22 ימים3:55

3:55

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

לפני 23 ימים3:21

3:21

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

לפני 24 ימים3:31

3:31

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

לפני 25 ימים4:50

4:50

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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The Launch 17:48

לפני 26 ימים17:48

17:48

We test, we launch.על ידי The QA Files

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EU IVDR: Strengthening Your MedTech Supply Chain Controls 4:43

לפני 26 ימים4:43

4:43

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

לפני 27 ימים4:03

4:03

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

לפני 28 ימים4:33

4:33

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

לפני 29 ימים4:03

4:03

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

לפני שנה5:19

5:19

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

לפני שנה5:10

5:10

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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New Meta Podcast Episode 140: Diablo 3 Season 23 Dates, Magic: Legends 1:46:04

לפני שנתיים1:46:04

1:46:04

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!על ידי New Meta Podcast

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New Meta Podcast Episode 139: POE Harvest Controversy, D2R Survey 2:20:30

לפני שנתיים2:20:30

2:20:30

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!על ידי New Meta Podcast

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New Meta Podcast Episode 138: Diablo 4 Main Stat, Diablo 2 Files Resurrected, D3 PTR 2.0 2:14:51

לפני שנתיים2:14:51

2:14:51

על ידי New Meta Podcast

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New Meta Podcast Episode 137: Diablo 3 2.7.0 PTR Feedback 2:17:45

לפני שנתיים2:17:45

2:17:45

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!על ידי New Meta Podcast

1
New Meta Podcast Episode 136: BlizzCon D4 QA Panel, Diablo 3 2.7.0 Patch 2:59:02

לפני שנתיים2:59:02

2:59:02

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!על ידי New Meta Podcast

1
New Meta Podcast Episode 135: BlizzCon 2021 Day 1 1:52:48

לפני שנתיים1:52:48

1:52:48

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!על ידי New Meta Podcast

1
New Meta Podcast Episode 134: BlizzCon Schedule 2:46:19

לפני שנתיים2:46:19

2:46:19

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!על ידי New Meta Podcast

1
New Meta Podcast Episode 133: Project Fenway 1:55:58

לפני שנתיים1:55:58

1:55:58

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!על ידי New Meta Podcast

1
New Meta Podcast Episode 132: BlizzConline Art, 30 Year Anniversary 2:18:44

לפני שנתיים2:18:44

2:18:44

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!על ידי New Meta Podcast

1
New Meta Podcast Episode 131: Vicarious Visions Merger 1:55:13

לפני שנתיים1:55:13

1:55:13

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!על ידי New Meta Podcast

1
New Meta Podcast Episode 130: Ritual Week 1 1:50:31

לפני שנתיים1:50:31

1:50:31

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!על ידי New Meta Podcast

1
New Meta Podcast Episode 129: POE Echoes of Fate 1:45:53

לפני שנתיים1:45:53

1:45:53

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!על ידי New Meta Podcast

1
New Meta Podcast Episode 128: Charms, Gems & Jewels, POE drops & Trivia 1:19:15

לפני שנתיים1:19:15

1:19:15

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!על ידי New Meta Podcast

1
New Meta Podcast Episode 127: Pay to Win 1:50:35

לפני שנתיים1:50:35

1:50:35

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!על ידי New Meta Podcast

1
New Meta Podcast Episode 126: Diablo Immortal Alpha 1:39:48

לפני שנתיים1:39:48

1:39:48

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!על ידי New Meta Podcast

1
New Meta Podcast Episode 125: Q4 Diablo 4 Update 1:46:47

לפני שנתיים1:46:47

1:46:47

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!על ידי New Meta Podcast

1
New Meta Podcast Episode 124: S22 Week 2, New Diablo CM 1:27:55

לפני שנתיים1:27:55

1:27:55

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!על ידי New Meta Podcast

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פודקאסטים בנושא The Qa Files

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