Best Qms Podcasts (2026)

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Navigating Mexico's IVD Market: COFEPRIS Compliance and the Distributor Gateway 3:22

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6h ago3:22

3:22

This episode explores the strategic necessity for In-Vitro Diagnostic (IVD) manufacturers to partner with specialized, full-service distributors when entering the Mexican market. We discuss the regulatory landscape governed by COFEPRIS, the critical role of the Mexican Registration Holder (MRH), and how an integrated distributor model not only faci…

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Mexico's IVD Market: Mastering COFEPRIS & Distributor Strategy 3:00

3h ago3:00

3:00

This episode explores the process of entering Mexico's In-Vitro Diagnostics (IVD) market. We examine the regulatory landscape managed by COFEPRIS, the critical role of a Mexico Registration Holder (MRH), and the strategic implications of choosing a local partner. Using the prominent distributor DIAC as an example, we differentiate between the regul…

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Mexico's IVD Market Expansion: A Distributor Strategy with PIDSA 3:25

16h ago3:25

3:25

This episode explores the pivotal role of local distributors in Mexico's burgeoning in-vitro diagnostics (IVD) market, using Proveedor Integral de Diagnóstico (PIDSA) as a case study. We analyze how specialized distributors provide essential infrastructure, including cold chain logistics and technical support, to help foreign medical device manufac…

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Medical Imaging & Radiology in Mexico: The Medical Prado Case Study 3:13

2h ago3:13

3:13

This episode explores Mexico's medical device market through a profile of Medical Prado, a leading distributor for medical imaging and radiology equipment. We analyze their role as an authorized Mindray dealer, the value-added services they provide, and their strategic focus on key regions like CDMX, Edomex, and Jalisco. This case study offers cruc…

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Partnering for Success: Navigating Mexico's Medical Imaging Sector 2:51

9h ago2:51

2:51

This episode explores the strategic advantages of partnering with specialized local distributors to enter Mexico's medical imaging and radiology market. We analyze the case of XRG Especialidades Médicas, a distributor with over 25 years of experience, to understand how their model of providing turnkey solutions, sales, and after-sales service helps…

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Episode 34 -S3 - ISO 9001 - How to Better Your Employee Engagement in a Culture of Quality 21:55

6h ago21:55

21:55

In this episode of The Quality Hub, Chatting with ISO Experts, host Xavier Francis shares standout moments from past guests to explore how a true culture of quality—grounded in ISO 9001—can significantly boost employee engagement. The discussion explains why ISO 9001 isn’t just about compliance, but about creating clarity, consistency, and support …

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Mexico's Radiology Market: A Distributor's Role with Agfa, Philips, and IMADINE 2:43

6h ago2:43

2:43

This episode explores the intricacies of Mexico's medical imaging and radiology market. We focus on the crucial role of local distributors by examining IMADINE, an authorized partner for global giants like Agfa and Philips. We discuss their portfolio, which includes ultrasound, X-ray, CT, and MRI equipment, and their value-added services such as si…

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Unlocking Mexico: A Strategic Guide to Orthopedic & Trauma Device Distribution 3:17

27m ago3:17

3:17

This episode explores the strategic nuances of entering Mexico's orthopedic and trauma medical device market. We analyze the successful distribution model of DAONSA Implantes, a key player that partners with global brands like ConMed and Enovis. We discuss how their focus on specialized clinical support, surgeon education, and workflow integration …

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The MDS Guru - Episode 75 - The Many Look Back Periods on the MDS 5:25

7h ago5:25

5:25

Send us a text The MDS has several look back periods. Do you know what they are? Support the showBy Melinda Renshaw, RN, RAC-CTA, Reimbursement Specialist

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COFEPRIS Registration & Market Strategy for Orthopedic Devices in Mexico 3:08

21m ago3:08

3:08

This episode explores the strategic importance of local partnerships for medical device market access in Mexico, using orthopedic and trauma device distributor IMTRA as a case study. We discuss the role of the Mexican regulatory authority, COFEPRIS, the necessity of holding local registrations, and how a specialized distributor provides essential c…

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Mexico's Orthopedic Implants Market: Navigating COFEPRIS Regulations & Trauma Sector Growth 3:29

4d ago3:29

3:29

This episode explores Mexico's dynamic orthopedic and trauma device market, detailing its significant growth drivers, including medical tourism and an expanding private healthcare sector. We provide a clear overview of the regulatory landscape managed by COFEPRIS, including device classification, the crucial role of a Mexican Registration Holder (M…

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Mexico Market Access: The Role of Specialized Distributors in Interventional Cardiology & Radiology 3:01

7h ago3:01

3:01

This episode examines the strategic importance of specialized local distributors for medical device market access, using DPM Distribuidores de Productos Médicos in Mexico as a case study. We explore how DPM's focus on interventional cardiology and radiology provides a crucial advantage for manufacturers entering the complex Mexican healthcare marke…

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Accessing Mexico’s MedTech Scene: A Case Study in Interventional Cardiology and Radiology 3:21

7h ago3:21

3:21

This episode explores Mexico's advanced medical device market through a case study of Endomédica, a leading distributor in interventional cardiology and radiology. We analyze how their specialized focus, clinical support, and integrated solutions model make them a key player and an ideal partner for international manufacturers seeking to enter the …

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Mexico's COFEPRIS Approval: Fast-Tracking Cardiology & Radiology Devices 3:17

1d ago3:17

3:17

This episode explores the lucrative Mexican market for interventional cardiology and radiology devices, detailing the COFEPRIS registration process. We cover the mandatory appointment of a Mexico Registration Holder (MRH), device classification, and the critical differences between the standard and expedited Equivalency Pathways. Learn how leveragi…

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Episode 33 - S3 - Leading Through Change 19:53

8d ago19:53

19:53

In this highlight episode of The Quality Hub: Chatting with ISO Experts, we revisit the most powerful insights from past conversations on leading through change. Across challenges and uncertainty, our featured moments explore what it means to stay steady under pressure, lead with authenticity, and turn disruption into opportunity. From practical to…

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Brazil's Dental Market: Unlocking Access with Key Distributors like Dental Speed 3:04

10d ago3:04

3:04

This episode explores Brazil's lucrative dental device market, highlighting the critical role of established local distributors for successful market entry. We focus on Dental Speed, a principal distributor founded in 1996, as a case study to understand how strategic partnerships are essential for navigating Brazil's complex regulatory landscape, m…

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Brazil's Dental Market: Unlocking Access with Dental Cremer and Henry Schein 2:54

3d ago2:54

2:54

This episode provides a deep dive into Dental Cremer, a Henry Schein company, and its dominant role in the Brazilian dental device market. We explore how its massive e-commerce platform, sophisticated nationwide logistics, and unique financing options create a powerful distribution channel. For international MedTech manufacturers, understanding Den…

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The MDS Guru - Episode 74 - How Will the Missouri Medicaid CMI Be Calculated When New Assessments Are Not Supported In 2026 3:39

3d ago3:39

3:39

Send us a text Do the assessments automatically drop to .62 CMI if they are not supported? Do you know what a hierarchical method of CMI classification is? Support the showBy Melinda Renshaw, RN, RAC-CTA, Reimbursement Specialist

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Brazil's Diagnostic Imaging Boom: Navigating Market Entry After ANVISA's 2024 Regulatory Shift 3:16

4d ago3:16

3:16

This episode explores Brazil's rapidly growing diagnostic imaging market, a key area for global MedTech companies like Philips Healthcare. We analyze the market's projected growth to USD 1.73 billion by 2030, the primary drivers behind this expansion, and the significant impact of ANVISA's June 2024 regulatory changes, which now recognize approvals…

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Siemens Healthineers: AI, CT, and Cardiology Imaging in Brazil 2:57

5d ago2:57

2:57

This episode explores Siemens Healthineers' significant role in Brazil's diagnostic imaging market. We cover their extensive portfolio of CT, MR, angiography, and ultrasound systems, their strategic expansion into diverse regions of the country, and their focus on integrating advanced technologies like Artificial Intelligence. Learn about specific …

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GE HealthCare's Brazil Strategy: Localizing Diagnostic Imaging Manufacturing 2:57

6d ago2:57

2:57

This episode delves into GE HealthCare's strategic investment in Brazil, examining the establishment of its first diagnostic imaging manufacturing facility in South America. We explore the timeline, from the 2008 announcement to the 2010 factory opening in Contagem, and analyze the "In Latin America, For Latin America" initiative. The discussion co…

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DePuy Synthes in Brazil: Navigating ANVISA's RDC 751/2022 for Orthopedic Devices 4:05

7d ago4:05

4:05

This episode examines the Brazilian market for orthopedic medical devices, using DePuy Synthes (a J&J MedTech company) as a case study. We break down the essential regulatory requirements set by ANVISA, including the pivotal RDC 751/2022 resolution, device classification, the mandatory Brazilian Registration Holder (BRH), and Good Manufacturing Pra…

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Zimmer Biomet in Brazil: A Blueprint for Orthopedic Device Market Access & ANVISA Compliance 3:11

8d ago3:11

3:11

This episode explores the strategic pathway for medical device market entry into Brazil, the largest MedTech market in Latin America. We analyze the case of Zimmer Biomet Brasil Ltda. to illustrate the critical importance of establishing a local subsidiary, securing a Brazil Registration Holder (BRH), and navigating the complex regulatory landscape…

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Episode 32- S3 -Transition Talk ISO Updates 45001-2027 Update 24:19

8d ago24:19

24:19

In this episode of The Quality Hub: Chatting with ISO Experts, host Xavier Francis is joined by Stuart Kelly and Kevin Franklin of LRQA to explore the upcoming wave of ISO standard updates, including the major revision to ISO 45001 expected by 2027. The discussion highlights how these changes reflect a shift toward sustainability, resilience, data-…

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Cracking the Brazilian Market: How Stryker Dominates Orthopedic Device Distribution 3:17

9d ago3:17

3:17

This episode examines Stryker do Brasil's successful strategy for dominating the Brazilian orthopedics market. We explore their extensive national distributor network, the specific product lines covered, and how their transparent, service-oriented approach provides crucial support to surgical teams, offering a powerful case study for medical device…

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

10d 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…

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The MDS Guru - Episode 73 - The NEW 1-1-26 Exclusion for the (L) Antipsychotic Med QM + The Conclusion of our QM Series-Prevalence of Falls & Behavior Symptoms Affecting Others (L) 4:48

10d ago4:48

4:48

Send us a text What new item will stop the antipsychotic med (L) QM from triggering? What is the updated RAI definition regarding a fall? Support the showBy Melinda Renshaw, RN, RAC-CTA, Reimbursement Specialist

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

11d 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

12d 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

13d 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…

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

14d 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

15d 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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Episode 31 - S3 - Common Pitfalls of Internal Auditing Program 20:03

15d ago20:03

20:03

In this episode of The Quality Hub, host Xavier Francis welcomes Tracey Bear, Manager of Audit Services at Core Business Solutions, to explore the common pitfalls of internal auditing programs. Tracy shares her extensive background—from rocket science to audit management—and offers practical advice on turning audits from “check-the-box” tasks into …

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

16d 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

27d 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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The MDS Guru - Episode 72 - How To Claim Isolation for Covid on the MDS 4:23

17d ago4:23

4:23

Send us a text What is needed in my documentation for Covid to claim isolation on the MDS? What if my MDS interview signatures are late? Support the showBy Melinda Renshaw, RN, RAC-CTA, Reimbursement Specialist

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

21d 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

29d 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

30d 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

25d 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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Perspectives from Paris: What's on the Horizon for 2026 12:39

22d ago12:39

12:39

In this special edition, I bring you highlights from our 2025 Ennov Europe User Meeting in Paris, where I spoke with four regulatory leaders from across the industry. I asked each of them the same three questions about their biggest priorities, challenges, and innovation, so you can compare perspectives, borrow what works, and plan ahead for 2026. …

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

22d 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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Episode 30 - S3 - ISO 9001 - Continuous Improvement Tools 20:20

22d ago20:20

20:20

In this episode of The Quality Hub: Chatting with ISO Experts, host Xavier Francis welcomes back Kate Behr, consultant at Core Business Solutions, for a deep dive into the practical tools that drive continuous improvement under ISO 9001. Together, they unpack essential concepts like the Plan-Do-Check-Act (PDCA) cycle, root cause analysis, internal …

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

23d 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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The MDS Guru - Episode 71 - Number of Outpatient ED Visits per 1000 (L) Resident Days & (L) % of Residents With New or Worsened Bowel or Bladder Incontinence QMs 5:15

24d ago5:15

5:15

Send us a text My resident's ER visit turned into an admission. Will this ER visit trigger this QM? My resident's cognition changed from a stroke, will his worsening continence trigger this? Support the showBy Melinda Renshaw, RN, RAC-CTA, Reimbursement Specialist

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

24d 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

25d 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

1M 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

27d 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

28d 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…