सर्वश्रेष्ठ The Qa Files पॉडकास्टस (2025)

1
Unlocking the Brazilian MedTech Market: ANVISA's Reliance Route & High-Risk Cardiology Devices 3:13

1d ago3:13

3:13

This episode explores the lucrative but complex medical device market in Brazil, the largest in Latin America. Using Abbott's Cardiac Rhythm Management (CRM) division as a practical example, we break down the critical regulatory requirements for high-risk devices. We cover the role of the national authority, ANVISA, the essential RDC 751/2022 regul…

1
Brazil Market Access: Boston Scientific's Cardiology Playbook 2:56

2d ago2:56

2:56

This episode explores the strategic approach of Boston Scientific in the Brazilian medical device market, focusing on its cardiology and electrophysiology operations. We analyze how Boston Scientific do Brasil functions as a local wholesale trader, supports key product portfolios like stents and balloons, and leverages global resources for physicia…

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Brazil MedTech Market: A Medtronic Cardiology Case Study on Long-Term Success 2:49

3d ago2:49

2:49

This episode analyzes how Medtronic has achieved long-term success in Brazil's complex cardiology device market. We explore their strategy of combining product distribution with extensive clinical support and training to navigate regulatory hurdles and a dual healthcare system, a model established since their entry in 1971.- How did Medtronic build…

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Global MedTech Expansion: Key Strategies for Market Access in the US, EU, and Asia 2:59

3d ago2:59

2:59

This episode breaks down the core components of a successful global market access strategy for MedTech and IVD companies. We explore the importance of building a proactive regulatory roadmap, the challenges of tailoring technical dossiers for different international markets like the US, EU, and Asia, and the critical role of local representation an…

1
McKesson's 2025 Spin-Off: A New Era for US Medical Device Distribution 3:20

5d ago3:20

3:20

This episode delves into McKesson's major announcement from May 2025 to spin off its Medical-Surgical Solutions (MMS) division into a new, independent company. We explore the strategic rationale behind this decision and what it means for the US medical device distribution landscape. We analyze the specific role of MMS in serving alternate-site prov…

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Cardinal Health's GMPD: A Deep Dive into US Medical Distribution Strategy for 2025 2:22

6d ago2:22

2:22

This episode provides a detailed analysis of Cardinal Health's Global Medical Products & Distribution (GMPD) segment, a dominant force in the U.S. medical supply market. We explore its business model, recent financial performance through FY2024 and FY2025, and its strategic importance for healthcare providers. The discussion covers how its private-…

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The Medline Advantage: U.S. Market Dominance and a Landmark 2025 IPO 2:34

7d ago2:34

2:34

This episode explores Medline Industries, the top medical-surgical distributor in the United States. We uncover the immense scale of its operations, its unique business model that combines distribution with in-house manufacturing, and the significant details surrounding its upcoming high-profile IPO planned for 2025, which is poised to be one of th…

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The US Hearing Aid Boom: Decoding the FDA's OTC Rule and 2025 Market Strategy 2:53

8d ago2:53

2:53

This episode explores the transformation of the U.S. hearing aid market following the FDA's landmark 2022 rule that established an over-the-counter (OTC) category. We analyze the impact on accessibility, device innovation, and affordability, while also examining the continued importance of the prescription hearing aid channel. The discussion covers…

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CPAP & APAP Technology: Navigating the Booming US Sleep Apnea Market 2:51

9d ago2:51

2:51

This episode explores the robust and growing U.S. market for Continuous Positive Airway Pressure (CPAP) and Automatic Positive Airway Pressure (APAP) devices used to treat obstructive sleep apnea (OSA). We delve into the key factors driving sustained, double-digit demand, including the high prevalence of OSA among American adults. The discussion al…

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Pacemakers and ICDs in 2024-2025: Key Global Market and Technology Shifts 3:00

10d ago3:00

3:00

This episode explores the dynamic landscape of Cardiac Implantable Electronic Devices (CIEDs), including pacemakers, ICDs, and CRT devices. We discuss why these devices are now a routine therapy, driven by an aging population and technological advancements. We cover key innovations like leadless technology, remote monitoring, and MRI-conditional la…

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U.S. Joint Arthroplasty Trends: Robotics, Demographics, and the 2025 Implant Market 3:09

11d ago3:09

3:09

This episode delves into the U.S. market for hip and knee replacement implants, analyzing data from the American Joint Replacement Registry’s 2024 report. We explore the procedural volumes, key market trends for 2025 such as the shift to outpatient settings, the rise of robotics, and the growing demographic of younger patients seeking joint arthrop…

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US Market Access: How CMS Reimbursement Fueled the CGM and Insulin Pump Boom 2:58

12d ago2:58

2:58

This episode explores the rapid adoption of Continuous Glucose Monitors (CGMs) and insulin pumps in the United States, detailing how changes in reimbursement policy, specifically from the Centers for Medicare & Medicaid Services (CMS) in April 2023, transformed these devices from niche products to mainstream standards of care for a growing number o…

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AI-Powered MedTech Regulation: Slashing Global Market Access Time by 75% 3:22

13d ago3:22

3:22

This episode explores how MedTech companies are leveraging advanced AI agents to overcome traditional hurdles in global medical device regulation. We discuss the shift from slow, manual processes to an automated, intelligent strategy that monitors real-time regulatory changes, streamlines technical dossier preparation for over 30 markets, and accel…

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AI in MedTech Regulation: 70% Faster FDA Submissions & Japan Compliance Case Studies 3:19

14d ago3:19

3:19

This episode explores real-world case studies of MedTech companies using advanced AI agents to accelerate FDA submissions, expand into multiple European markets simultaneously, and maintain compliance in complex regions like Japan. We break down how AI is reducing preparation times by 70%, driving revenue growth by 300%, and preventing costly regul…

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Unlocking Global Markets: End-to-End Regulatory Services for MedTech and IVD Devices 2:55

15d ago2:55

2:55

This episode details the full range of medical devices and regulatory services supported for global market access. We explain our expertise with both MedTech and In-Vitro Diagnostic (IVD) products, from simple tools to complex software. The discussion covers the complete lifecycle of our services, including initial regulatory strategy, AI-powered t…

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Scaling MedTech: Tailored Regulatory Strategies for Startups, Scaleups, and Global Enterprises 2:50

16d ago2:50

2:50

This episode explores how regulatory strategies for MedTech and IVD devices must adapt to a company's growth stage. We discuss the unique challenges and tailored solutions for startups seeking initial market entry, scaleups planning international expansion, and multinational enterprises managing complex global portfolios. Learn how a strategic appr…

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Beyond Traditional Consulting: The Future of IVD and MedTech Market Access 2:59

17d ago2:59

2:59

This episode explores the evolution of regulatory consulting for MedTech and IVD devices. We contrast the traditional, fragmented consulting model with Pure Global's integrated, technology-driven approach. Discover how AI, a unified global-local team, and an end-to-end service model are revolutionizing how companies achieve faster, more efficient m…

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Unlocking Global MedTech Markets: A Unified Strategy for Registration in the US, EU, and Asia 2:40

18d ago2:40

2:40

This episode explores how MedTech and IVD companies can overcome the complexities of international expansion. We discuss a unified, technology-driven approach to registering medical devices in over 30 global markets simultaneously, covering everything from initial regulatory strategy and market selection to the role of local representation and AI-p…

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MedTech Market Entry: The True Cost of Free vs. Paid Regulatory Resources 2:50

19d ago2:50

2:50

This episode breaks down the crucial differences between free and paid resources in the complex world of medical device market access. We explore what you can achieve with publicly available information from regulatory bodies and when it becomes essential to invest in expert services for strategy, submission, and reimbursement to ensure a successfu…

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Beyond the SaaS Hype: Real AI-Powered Global Market Access for MedTech 2:51

20d ago2:51

2:51

This episode explores the critical distinction between standalone AI SaaS tools and a fully integrated, service-based approach for MedTech global market access. We dissect why expensive software alone often falls short and how combining advanced AI with on-the-ground human expertise, local representation, and end-to-end regulatory services provides…

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MedTech Expansion Strategy: Unlocking Underserved Global Markets in LATAM and APAC 2:57

21d ago2:57

2:57

This episode explores the strategies and regulatory hurdles involved in bringing medical devices to underserved and emerging global markets. We discuss how to leverage existing approvals, the critical role of local representation, and the use of technology to streamline multi-country submissions, focusing on promising regions like Latin America and…

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AI in MedTech Regulatory Affairs: Scaling to 30+ Global Markets 2:50

22d ago2:50

2:50

This episode explores how Artificial Intelligence is revolutionizing the medical device registration process, breaking down financial barriers and enabling broader global market access. We discuss the shift from costly, manual submissions to an efficient, technology-driven model that allows MedTech companies of all sizes to bring life-saving innova…

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Free AI Agents: The Future of Medical Device Registration in the US, EU, and Beyond 2:51

23d ago2:51

2:51

This episode explores the transformative impact of free AI-powered tools on the medical device industry. We discuss how making regulatory intelligence and global device databases accessible at no cost is breaking down financial barriers, enabling MedTech companies to expand their reach into new international markets more efficiently and affordably.…

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Colombia Medical Device Registration: Unpacking Decree 4725 of 2005 3:16

24d ago3:16

3:16

This episode provides a detailed overview of Colombia's foundational medical device regulation, Decree 4725 of 2005. We explore the critical role of INVIMA, the risk-based classification system, key submission requirements for market approval, and post-market surveillance obligations for MedTech and IVD manufacturers looking to enter the Colombian …

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Mexico's Technovigilance: Mastering COFEPRIS NOM-240 for Post-Market Success 3:12

25d ago3:12

3:12

This episode provides a detailed overview of Mexico's Technovigilance requirements for medical devices under COFEPRIS regulation NOM-240-SSA1-2012. We explore the mandatory post-market surveillance system, including the roles of the Sanitary Registration Holder, adverse event reporting timelines, and the documentation required for registration rene…

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Mexico's New Medical Device Labeling Standard: A Deep Dive into NOM-137-SSA1-2024 3:07

26d ago3:07

3:07

This episode provides a critical update on Mexico's new mandatory standard for medical device labeling, NOM-137-SSA1-2024. The host breaks down the key changes from the previous 2008 version, including the strict Spanish language requirement, new provisions for electronic labeling and Software as a Medical Device (SaMD), and updated rules for symbo…

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Navigating NOM-241-SSA1-2021: Medical Device GMP Compliance in Mexico 3:15

27d ago3:15

3:15

This episode provides a detailed overview of Mexico's mandatory Good Manufacturing Practices (GMP) standard, NOM-241-SSA1-2021. The host breaks down the key requirements for medical device manufacturers, including the implementation of a Quality Management System, risk management protocols, and alignment with ISO 13485. We discuss the standard's sc…

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Navigating COFEPRIS: A Deep Dive into Mexico's 'Reglamento de Insumos para la Salud' for Medical Devices 3:24

28d ago3:24

3:24

This episode provides a detailed overview of Mexico's medical device regulations, focusing on the Reglamento de Insumos para la Salud. We explore the role of the regulatory authority, COFEPRIS, the risk-based device classification system, and the available registration pathways, including the Standard and Equivalency routes. The host also covers th…

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Mexico's COFEPRIS Framework: A Deep Dive into the Ley General de Salud for Medical Devices 2:54

29d ago2:54

2:54

This episode provides a comprehensive overview of Mexico's foundational health regulation, the Ley General de Salud, and its impact on medical device market access. We explore the role and authority of the regulatory body, COFEPRIS, and break down the key requirements manufacturers must meet, from pre-market registration and GMP compliance to post-…

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Brazil GMP Certification: A Deep Dive into RDC 687/2022 for Class III/IV Devices 3:16

1M ago3:16

3:16

This episode provides a detailed analysis of Brazil's RDC 687/2022, a critical regulation from ANVISA governing Good Manufacturing Practices (GMP) certification for Class III and IV medical device manufacturers. We explore the key requirements, audit procedures, and documentation needed to secure the mandatory CBPF certificate, highlighting the cha…

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Navigating Brazil's ANVISA Technovigilance: A Deep Dive into RDC 67/2009 Reporting Timelines 3:13

1M ago3:13

3:13

This episode provides a detailed overview of Brazil's key technovigilance regulations for medical devices, RDC 67/2009 and RDC 551/2021. We explore the mandatory requirements for post-market surveillance, the critical role of the Brazilian Registration Holder (BRH), and the specific, strict timelines set by ANVISA for reporting adverse events, malf…

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Brazil's BGMP Overhaul: Navigating ANVISA RDC 665/2022 and MDSAP Compliance 3:07

1M ago3:07

3:07

This episode explores Brazil's key regulation for medical device and IVD manufacturers, ANVISA RDC 665/2022. We break down the Brazilian Good Manufacturing Practices (BGMP) requirements, its alignment with international standards like ISO 13485, its replacement of the former RDC 16/2013, and its crucial integration with the Medical Device Single Au…

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Brazil's IVD Shake-up: ANVISA RDC 830/2023 and New Risk Classifications 3:10

1M ago3:10

3:10

This episode provides a detailed analysis of Brazil's new IVD regulation, ANVISA RDC 830/2023, which was implemented in June 2024. We explore the critical changes to risk classification systems, which align with international standards and result in the up-classification of many devices. The discussion covers the impact on regulatory pathways, tech…

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ANVISA RDC 751/2022: A Manufacturer's Guide to Brazilian Device Registration 3:36

1M ago3:36

3:36

This episode provides a detailed overview of Brazil's pivotal medical device regulation, ANVISA RDC 751/2022, which became effective in March 2023. We explore its comprehensive framework, including the four-tier risk classification system, the distinct pathways for notification and registration, and its alignment with international standards like t…

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Singapore MedTech: How to Break Free from Distributor Lock-In 3:44

1M ago3:44

3:44

This episode delves into the critical process for medical device manufacturers to regain control of their Singapore market access by transitioning from a distributor-held registration to an independent registrant. We explain why tying your regulatory license to a commercial partner creates business risks and outline the strategic advantages and pro…

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Unlocking Your MedTech in Vietnam: The Registration Holder Dilemma 2:51

1M ago2:51

2:51

This episode delves into the critical process of changing a medical device registration holder in Vietnam. We clarify a common misconception: a direct license transfer between holders is not permitted by the Ministry of Health. Instead, manufacturers must navigate a full re-registration process. We outline the steps involved and highlight the signi…

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Japan's D-MAH System: Regaining Control of Your Medical Device 3:09

1M ago3:09

3:09

This episode explores the critical strategic choice between appointing a distributor versus an independent Designated Marketing Authorization Holder (D-MAH) for medical device registration in Japan. We break down how using an independent D-MAH allows foreign manufacturers to retain ownership of their marketing approvals, providing essential flexibi…

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Australia TGA Sponsor: How to Take Control of Your Medical Device Registration 2:43

1M ago2:43

2:43

This episode delves into the strategic process of changing a TGA Sponsor for medical devices in Australia. We explore the critical differences between using a distributor as a sponsor versus an independent sponsor, outlining the risks of the former and the long-term benefits of the latter. Learn about the official transfer process, the importance o…

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Unlocking India: The Strategic Advantage of an Independent Authorized Agent 3:23

1M ago3:23

3:23

This episode explores the critical process of switching your Indian Authorized Agent (IAA) with the CDSCO, moving from a commercially-tied distributor to an independent regulatory partner. We detail the significant business risks of using a distributor as your agent and provide a step-by-step guide for making the change, including the crucial role …

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Regain Control: Transferring Your ANMAT Registration in Argentina 3:06

1M ago3:06

3:06

This episode delves into the critical process of transferring ANMAT medical device registration in Argentina from a distributor to an independent holder. We explore the strategic risks of distributor-held registrations, such as commercial lock-in, and provide a clear overview of the transfer process, including the role of the Argentina Authorized R…

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Unlock Chile: Why Your Distributor Shouldn't Own Your Medical Device Registration 3:02

1M ago3:02

3:02

This episode explores a crucial, often overlooked aspect of entering the Chilean medical device market: the selection of an in-country registration holder. We detail the significant risks of appointing a distributor as your registration holder with the Instituto de Salud Pública (ISP), including loss of market control and conflicts of interest. The…

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Regain Control: Switching Your Medical Device Registration Holder in Peru 3:00

1M ago3:00

3:00

This episode explores the critical risks of allowing a distributor to hold your medical device registration in Peru and outlines the strategic advantages of using an independent Peru Registration Holder (PRH). We discuss how this decision impacts your market control, business flexibility, and long-term security. Learn about the process of transferr…

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Mexico MedTech: Untangling Your COFEPRIS Registration Holder 3:12

1M ago3:12

3:12

This episode explores the critical process of transferring a medical device registration holder in Mexico. We uncover the risks of appointing a distributor as your legal representative with COFEPRIS and detail the complex legal steps required for a transfer of rights. Learn why choosing an independent registration holder from the outset is the key …

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Regain Control: Switching Your INVIMA Holder in Colombia 3:13

1M ago3:13

3:13

This episode explores the critical decision of who holds your INVIMA medical device registration in Colombia. We delve into the significant business risks of allowing a distributor to be the registration holder and outline the strategic advantages of using an independent third party. Learn about the process for transferring ownership, the potential…

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Brazil's MedTech Market: Escaping the Distributor Trap 2:52

2M ago2:52

2:52

This episode delves into a crucial aspect of the Brazilian medical device market: the role of the Brazil Registration Holder (BRH). We explore the significant differences and long-term consequences of appointing a distributor versus an independent third party to hold your device registration with ANVISA. Learn how to avoid common pitfalls that can …

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UAE Regulatory Update: Gaining Control with an Independent LAR 3:23

2M ago3:23

3:23

This episode explores the pivotal regulatory change in the United Arab Emirates allowing medical device manufacturers to appoint an independent Local Authorized Representative (LAR), decoupling registration from commercial distribution. We analyze the risks of the old distributor-as-LAR model and highlight the strategic advantages of the new system…

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Turkey's New Medical Device Rule: Why Your Distributor Is Now a Liability 3:24

2M ago3:24

3:24

This episode unpacks a crucial change in Turkey's medical device regulations following its alignment with the EU MDR on June 2, 2021. We explore why foreign manufacturers can no longer use their commercial distributors as their Turkish Authorized Representative (TR-REP). The discussion focuses on the inherent conflict of interest between sales and …

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SFDA Success: Regain Control by Switching Your Saudi Authorized Representative 3:40

2M ago3:40

3:40

This episode explores the critical strategic decision for medical device manufacturers in Saudi Arabia: moving from a distributor-based Local Authorized Representative (LAR) to an independent one. We delve into the significant risks of tying your SFDA product registrations to a commercial partner and outline the clear benefits and straightforward p…

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Switzerland's CH-REP Rule: Is Your Distributor a Compliance Risk? 4:07

2M ago4:07

4:07

This episode delves into the critical role of the Swiss Authorized Representative (CH-REP) for medical device manufacturers. We explore the significant regulatory changes that made the CH-REP mandatory and uncover the hidden risks of appointing a commercial distributor for this function. Learn why an independent CH-REP is the more strategic choice …

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EU Medical Devices: Breaking Up with Your Distributor-AR in France 3:26

2M ago3:26

3:26

This episode explores the critical shift for medical device manufacturers from using a distributor as their EU Authorized Representative (EC-REP) to appointing a professional, independent representative in France. We delve into the increased liabilities under the MDR, the inherent conflicts of interest in the distributor model, and the significant …

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The Qa Files पॉडकास्टस

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