The American Journal of Neuroradiology (AJNR) is a scholarly, peer-reviewed journal that publishes Original Research and Review Articles relevant to the diagnostic, interventional, and functional imaging of the brain, head, neck, and spine. AJNR's monthly podcasts include a review of Editor's Choices and Fellows' Journal Club selections and an author interview. These podcasts are hosted by Francis Deng and George K. Vilanilam.
…
continue reading
Interventional Radiology Podcasts
The Society of Interventional Radiology (SIR) brings you a new podcast on all the topics that impact your practice of IR, with focused subseries reflecting the broad range of the specialty. In each episode, hosts and guests discuss new clinical opportunities, practice management tips, the latest trends and developments in the specialty, and more. Learn more on sirweb.org, irq.sirweb.org, and sirweb.org/kinkedwire. If you have any ideas for topics or guests, or have any other feedback, let us ...
…
continue reading
Welcome to the life of the Catheter Jockeys, where we put our spin on the field of Radiology in a fun and entertaining way. Your hosts will guide you through their experiences becoming the funnest and most knowledgeable X-ray techs to ever walk into that hospital break room. Listen weekly as we discuss the ups and downs of all things Radiology and Medical Imaging. Come have a laugh with us or mostly just laugh at us as we share all our stories with you! PS: Don't forget to Twerk the Histogram!
…
continue reading
Featuring real discussions on venous disease and treatment. We bring together leaders in the venous treatment world to talk about the latest developments, events, and discoveries relating to venous management and care. If you're involved in vein care, then this is the podcast for you.
…
continue reading
A podcast exploring subjects in the growing field of Interventional Radiology aimed at medical students, residents, fellows, and attendings. *If you have any feedback, please email us at [email protected] This podcast was founded by Sanna Herwald & Benjamin Roush and created by The Sound of IR team with collaboration from SIR members. *Music for our epsiodes is [Balloons Rising](http://freemusicarchive.org/music/A_A_Aalto/Bright_Corners/) by A. A. Aalto* *From the [Free Music Archive](h ...
…
continue reading
Pain & injury are part of our life experience. A Canadian sports injury and chronic pain physiotherapist since 1999, Grant Fedoruk shares his unique observations on pain, injury, business and life. He combines humour and laughs with interviews of his colleagues, patients and other experts in the field to learn how and why: Life Shouldn't Hurt.
…
continue reading
A podcast about medical student life and the journey to becoming a physician. Featuring survival tips, wellness strategies, inside scoop on major milestones, and interviews with inspirational faculty members, residents, and students. Join host Dr. Neda Frayha and find out what doctors wish they knew when they were in medical school. From the University of Maryland School of Medicine's Office of Student Affairs.
…
continue reading
my life, my struggle
…
continue reading
The Baylor College of Medicine Resonance Podcast is a student-run podcast aimed at showcasing the science at Baylor through the eyes of young professionals. Each episode is written and recorded by students who have a passion for research and the medical community. Guests on the show include both clinical and basic science research faculty who are experts in their fields. We hope that whoever listens in gains new insight into the exciting world of biomedical research.
…
continue reading
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 ...
…
continue reading
1
Perioperative Medicine Podcast Series
Monash University - Department of Anaesthesiology and Perioperative Medicine.
Perioperative Medicine Short Course is conducted by Monash University (Central Clinical School - Alfred Hospital), in conjunction with the Alfred Hospital and Department of Anaesthesiology and Perioperative Medicine. As part of our drive to improve and promote perioperative medicine education we are launching our PeriopMed podcast series.
…
continue reading
Welcome to your information source for all things relating to the physician assistant profession. While it's very desirable to become a PA, it's not easy to get there. From the extensive requirements of difficult prerequisites to having thousands of hours of experience, becoming a PA can be quite the challenge. Savanna Perry from The PA Platform Blog reveals all of her advice on how to reach your goals of becoming a PA. Savanna has been where you are and understands what it takes to look goo ...
…
continue reading
1
Accessing Mexico’s MedTech Scene: A Case Study in Interventional Cardiology and Radiology
3:21
3:21
Play later
Play later
Lists
Like
Liked
3:21This 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 …
…
continue reading
1
Insights on Interventional Radiology with Dr. Paige Reed
46:58
46:58
Play later
Play later
Lists
Like
Liked
46:58In this episode of Resonance, Gianni Calderara and Nithya Erabelli sit down with Dr. Paige Reed, an interventional radiologist at MD Anderson Cancer Center, to discuss her journey into IR, the variety and creativity of the field, and the unique opportunities it offers for patient care, procedural innovation, and research. Dr. Reed shares insights i…
…
continue reading
1
Precision Relief: Interventional Radiology Explained
39:23
39:23
Play later
Play later
Lists
Like
Liked
39:23In this episode of Life Shouldn’t Hurt, I sat down with Dr. Jason Motkoski, a physician and interventional radiologist from Canadian Diagnostic Centers. Many people think of radiology as simply reading X-rays or MRIs, but Dr. Motkoski explained how the field has advanced into what’s now called interventional radiology. This specialty uses imaging t…
…
continue reading
1
Mexico's COFEPRIS Approval: Fast-Tracking Cardiology & Radiology Devices
3:17
3:17
Play later
Play later
Lists
Like
Liked
3:17This 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…
…
continue reading
1
Brazil's Dental Market: Unlocking Access with Key Distributors like Dental Speed
3:04
3:04
Play later
Play later
Lists
Like
Liked
3:04This 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…
…
continue reading
1
Life Shouldn't Hurt Bob Steadward - Disability in Sport
39:19
39:19
Play later
Play later
Lists
Like
Liked
39:19The Paralympic Movement and Disability in Sport Welcome back to Life Shouldn't Hurt. It is almost 2026, and I am thrilled to kick off the new year with my guest host, Anita Cassidy. While we opened the show discussing our personal resolutions—including Anita’s shocking decision to drink her first cup of coffee after 49 years of abstinence, and our …
…
continue reading
1
Brazil's Dental Market: Unlocking Access with Dental Cremer and Henry Schein
2:54
2:54
Play later
Play later
Lists
Like
Liked
2:54This 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…
…
continue reading
1
Brazil's Diagnostic Imaging Boom: Navigating Market Entry After ANVISA's 2024 Regulatory Shift
3:16
3:16
Play later
Play later
Lists
Like
Liked
3:16This 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…
…
continue reading
1
Siemens Healthineers: AI, CT, and Cardiology Imaging in Brazil
2:57
2:57
Play later
Play later
Lists
Like
Liked
2:57This 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 …
…
continue reading
1
AI intracranial aneurysm detection feat. Babatunde Akinpelu
23:14
23:14
Play later
Play later
Lists
Like
Liked
23:14In this AJNR Author Interview, Dr. Francis Deng discusses with Dr. Babatunde Akinpelu the article "Assessing the Accuracy of Artificial Intelligence in Detecting Intracranial Aneurysms in a Clinical Setting Relative to Neuroradiologists." Neuroradiologists performed better than a commercial AI program for intracranial aneurysm detection in sensitiv…
…
continue reading
1
GE HealthCare's Brazil Strategy: Localizing Diagnostic Imaging Manufacturing
2:57
2:57
Play later
Play later
Lists
Like
Liked
2:57This 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…
…
continue reading
1
DePuy Synthes in Brazil: Navigating ANVISA's RDC 751/2022 for Orthopedic Devices
4:05
4:05
Play later
Play later
Lists
Like
Liked
4:05This 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…
…
continue reading
1
Zimmer Biomet in Brazil: A Blueprint for Orthopedic Device Market Access & ANVISA Compliance
3:11
3:11
Play later
Play later
Lists
Like
Liked
3:11This 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…
…
continue reading
1
Cracking the Brazilian Market: How Stryker Dominates Orthopedic Device Distribution
3:17
3:17
Play later
Play later
Lists
Like
Liked
3:17This 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…
…
continue reading
1
Pickleball, Patience, and Professional Coaching
38:49
38:49
Play later
Play later
Lists
Like
Liked
38:49If you’ve noticed tennis courts transforming or heard a distinct "pop-pop" sound at your local park, you aren’t alone. In this energetic episode of Life Shouldn’t Hurt, host Grant Fedoruk dives deep into the phenomenon of Pickleball—the fastest-growing sport in North America. Whether you are a seasoned athlete or someone looking to get off the couc…
…
continue reading
1
Unlocking the Brazilian MedTech Market: ANVISA's Reliance Route & High-Risk Cardiology Devices
3:13
3:13
Play later
Play later
Lists
Like
Liked
3:13This 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…
…
continue reading
1
Brazil Market Access: Boston Scientific's Cardiology Playbook
2:56
2:56
Play later
Play later
Lists
Like
Liked
2:56This 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…
…
continue reading
1
Brazil MedTech Market: A Medtronic Cardiology Case Study on Long-Term Success
2:49
2:49
Play later
Play later
Lists
Like
Liked
2:49This 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…
…
continue reading
1
Global MedTech Expansion: Key Strategies for Market Access in the US, EU, and Asia
2:59
2:59
Play later
Play later
Lists
Like
Liked
2:59This 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…
…
continue reading
1
McKesson's 2025 Spin-Off: A New Era for US Medical Device Distribution
3:20
3:20
Play later
Play later
Lists
Like
Liked
3:20This 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…
…
continue reading
1
Episode 71: ECS Contributions and innovations in IR with Brian Funaki, MD, FSIR
22:27
22:27
Play later
Play later
Lists
Like
Liked
22:27“I started off simply by volunteering to do things and being interested, but I didn’t have a mentor, per say.” – Brian Funaki, MD, FSIR In this episode of the Kinked Wire, host Thomas Tullius, Jr., MD, speaks with his former attending Brian Funaki, MD, FSIR, on his career progression, from trainee to incoming JVIR co-editor in chief. SIR thanks BD …
…
continue reading
1
Cardinal Health's GMPD: A Deep Dive into US Medical Distribution Strategy for 2025
2:22
2:22
Play later
Play later
Lists
Like
Liked
2:22This 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-…
…
continue reading
1
Living and Thriving with Type 1 Diabetes: 50 Years of Progress From Someone who Knows
38:39
38:39
Play later
Play later
Lists
Like
Liked
38:39Living with Type 1 diabetes is like having a job where you never get a day off. Constant vigilance, discipline, and resilience are required. In this inspiring episode of the Life Shouldn’t Hurt podcast, host Grant Fedoruk and co‑host Anita Cassidy sit down with Dave Prince, who shares his remarkable 50‑year journey managing diabetes while living a …
…
continue reading
1
The Medline Advantage: U.S. Market Dominance and a Landmark 2025 IPO
2:34
2:34
Play later
Play later
Lists
Like
Liked
2:34This 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…
…
continue reading
1
Episode 133: Applying to Dermatology Residency with 2025 Grad Dr. Emily Ma
19:00
19:00
Play later
Play later
Lists
Like
Liked
19:00Our series on applying to residency programs marches on with a deep dive into the Dermatology application process with SOM 2025 graduate, Dr. Emily Ma. She shares practical, down-to-earth advice for applying to such a competitive specialty.
…
continue reading
1
The US Hearing Aid Boom: Decoding the FDA's OTC Rule and 2025 Market Strategy
2:53
2:53
Play later
Play later
Lists
Like
Liked
2:53This 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…
…
continue reading
1
CPAP & APAP Technology: Navigating the Booming US Sleep Apnea Market
2:51
2:51
Play later
Play later
Lists
Like
Liked
2:51This 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…
…
continue reading
1
Pacemakers and ICDs in 2024-2025: Key Global Market and Technology Shifts
3:00
3:00
Play later
Play later
Lists
Like
Liked
3:00This 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…
…
continue reading
1
Frozen Shoulder: Freezing, Frozen, and Thawing
39:15
39:15
Play later
Play later
Lists
Like
Liked
39:15Is Your Shoulder "Frozen" or Just Stubborn? Why Movement is Medicine (Even When It Hurts) By Grant Fedoruk Welcome back to Life Shouldn't Hurt, the show where we believe your heart, body, and spirit deserve a little less struggle and a lot more kindness. If you’ve ever felt like life handed you lemons and forgot the recipe for lemonade, you’re in t…
…
continue reading
1
U.S. Joint Arthroplasty Trends: Robotics, Demographics, and the 2025 Implant Market
3:09
3:09
Play later
Play later
Lists
Like
Liked
3:09This 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…
…
continue reading
1
US Market Access: How CMS Reimbursement Fueled the CGM and Insulin Pump Boom
2:58
2:58
Play later
Play later
Lists
Like
Liked
2:58This 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…
…
continue reading
1
AI-Powered MedTech Regulation: Slashing Global Market Access Time by 75%
3:22
3:22
Play later
Play later
Lists
Like
Liked
3:22This 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…
…
continue reading
1
AI in MedTech Regulation: 70% Faster FDA Submissions & Japan Compliance Case Studies
3:19
3:19
Play later
Play later
Lists
Like
Liked
3:19This 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…
…
continue reading
1
Episode 132: Applying to Ophthalmology Residency with 2025 Grad Dr. Fernando Martinez Guasch
23:37
23:37
Play later
Play later
Lists
Like
Liked
23:37We are continuing our series on applying to residency programs, this time with a warm, wise conversation with Dr. Fernando Martinez Guasch. He graduated from the SOM in 2025 and is completing his internship year before pursuing an Ophthalmology residency. He shares so many insights about the Ophtho match and about navigating this time of life in ge…
…
continue reading
1
Unlocking Global Markets: End-to-End Regulatory Services for MedTech and IVD Devices
2:55
2:55
Play later
Play later
Lists
Like
Liked
2:55This 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…
…
continue reading
1
Scaling MedTech: Tailored Regulatory Strategies for Startups, Scaleups, and Global Enterprises
2:50
2:50
Play later
Play later
Lists
Like
Liked
2:50This 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…
…
continue reading
1
Beyond Traditional Consulting: The Future of IVD and MedTech Market Access
2:59
2:59
Play later
Play later
Lists
Like
Liked
2:59This 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…
…
continue reading
1
Unlocking Global MedTech Markets: A Unified Strategy for Registration in the US, EU, and Asia
2:40
2:40
Play later
Play later
Lists
Like
Liked
2:40This 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…
…
continue reading
1
MedTech Market Entry: The True Cost of Free vs. Paid Regulatory Resources
2:50
2:50
Play later
Play later
Lists
Like
Liked
2:50This 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…
…
continue reading
1
Beyond the SaaS Hype: Real AI-Powered Global Market Access for MedTech
2:51
2:51
Play later
Play later
Lists
Like
Liked
2:51This 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…
…
continue reading
In this AJNR article summary, Dr. Francis Deng reviews a study, from corresponding author Dr. Katherine Reinshagen, entitled "Retrospective Review of MR Findings in Sudden Sensorineural Hearing Loss and Associated Clinical Features". In this large cohort, the yield of MRI for relevant findings was 5.9%, including tumors in less than 3%. The spectru…
…
continue reading
1
MedTech Expansion Strategy: Unlocking Underserved Global Markets in LATAM and APAC
2:57
2:57
Play later
Play later
Lists
Like
Liked
2:57This 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…
…
continue reading
This recording features audio versions of the December 2025 Journal of Vascular and Interventional Radiology (JVIR) abstracts: Articles Association between Age of Kidney Transplant and Hemorrhagic Adverse Events Following Transplant Kidney Biopsy (Read) A Prospective Single-Arm Trial of Genicular Artery Embolization for Symptomatic Knee Osteoarthri…
…
continue reading
1
AI in MedTech Regulatory Affairs: Scaling to 30+ Global Markets
2:50
2:50
Play later
Play later
Lists
Like
Liked
2:50This 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…
…
continue reading
1
Free AI Agents: The Future of Medical Device Registration in the US, EU, and Beyond
2:51
2:51
Play later
Play later
Lists
Like
Liked
2:51This 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.…
…
continue reading
1
Colombia Medical Device Registration: Unpacking Decree 4725 of 2005
3:16
3:16
Play later
Play later
Lists
Like
Liked
3:16This 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 …
…
continue reading
1
Mexico's Technovigilance: Mastering COFEPRIS NOM-240 for Post-Market Success
3:12
3:12
Play later
Play later
Lists
Like
Liked
3:12This 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…
…
continue reading
1
Mexico's New Medical Device Labeling Standard: A Deep Dive into NOM-137-SSA1-2024
3:07
3:07
Play later
Play later
Lists
Like
Liked
3:07This 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…
…
continue reading
Mark H. Knelson, MD, thought his IR career had come to an early end—until he discovered locum tenens work. At the start of the COVID-19 pandemic, Dr. Knelson heard that one of the radiology groups in his town was short on IRs. Because it was so close to his home—approximately 13 minutes—he offered to help, including taking call as needed. In the au…
…
continue reading
1
Navigating NOM-241-SSA1-2021: Medical Device GMP Compliance in Mexico
3:15
3:15
Play later
Play later
Lists
Like
Liked
3:15This 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…
…
continue reading