Medtech Innovation Podcast: Spencer Jones dives deep into winning medtech startup strategies. Each episode unpacks hot takes and insider tactics from the trenches of medtech innovation. Join physician inventors, founders, engineers, and healthcare market makers as they share actionable insights to navigate the FDA, secure medtech funding, and drive medtech breakthroughs. No-nonsense advice to be a change maker in medtech.
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The Project Medtech podcast is interview-style podcast on the Medtech Industry where guests share stories, advice, pitfalls, trends and innovations produced by Project Medtech.
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MD+DI editors discuss current trends in the medical device and diagnostics industry, and point out developments to watch in the coming months.
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Discussions about Medical Technology, Pharmaceuticals and popular trends; covering from basic to complex topics in a simplified way to make you understand. Rodney is a Biomedical Engineer and co-inventor working in R&D, ex Johnson & Johnson.
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What's next in the future of health? Welcome to MedTech Global Insights, the podcast dedicated to uncovering the most disruptive technologies and brilliant minds in the medical field. Whether you're an industry professional, investor, or simply curious, subscribe for your dose of cutting-edge information and expert commentary.
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Welcome to LATAM MedTech Insights, your essential guide to the booming medical technology and digital health sector across Latin America. Each episode, we dissect the key trends, investment opportunities, and regulatory news shaping the industry. Join us for in-depth interviews with the innovators, investors, and policymakers driving the future of healthcare from Mexico to Brazil.
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Welcome to MENA MedTech Insights, the definitive podcast for professionals in the Middle East and North Africa's rapidly growing medical technology sector. Each episode, we explore the latest innovations, market trends, and regulatory landscapes, featuring exclusive interviews with the founders, investors, and leaders who are shaping the future of healthcare in the region.
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Welcome to ASEAN MedTech Insights, the premier podcast dedicated to the thriving medical technology landscape of Southeast Asia. Each episode, we explore the cutting-edge innovations, investment trends, and regulatory developments in one of the world's fastest-growing markets. Join us for exclusive interviews with the founders, executives, and visionaries shaping the future of healthcare in the ASEAN region.
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A weekly conversation with the innovators who will change how health care is delivered.
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Learn from the brightest CEOs in medtech and healthtech. That's our primary goal with Medsider. We unpack the strategies, tactics, and secrets behind the most successful startups. Join tens of thousands of ambitious doers and get access to the top medical device and health technology thought leaders.
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A podcast focused on the medical device technology industry, from design and development to outsourcing services and relationships to finished medtech products.
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Welcome to MedTech Trailblazers where Andrew Cleeland, CEO of Fogarty Innovation, hosts in-depth conversations with the disruptors and innovators in the field of medical technology. Join him as he shares their insightful stories, effective leadership styles and what they're doing to transform patient outcomes and shape the future of human health.
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Join us on DeviceAlliance's Podcast: MedTech Radio where we interview today's brightest minds in Southern California's medical device industry. Each episode deconstructs complex topics and provides the tactics, tools, and strategies to overcome tomorrow's challenges. DeviceAlliance strives to be the one-stop-shop at the center of the medical device ecosystem helping drive collaboration, innovation, and career development for all device professionals in Southern California.
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RQM+ is The MedTech CRO – a full-service partner supporting everything from groundbreaking innovation to well-established technologies. Our coordinated and comprehensive solutions are customized to each client’s product and life cycle stage. By aligning strategy and execution in one partner, we help reduce cost, accelerate timelines, and drive more successful outcomes. Visit RQMplus.com to see how we help MedTech companies of all sizes, spanning all device types and therapeutic areas. This p ...
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We believe in enabling innovation within the MedTech industry. We are an educational platform that supports early-stage entrepreneurs interested in being successful in the medical device space. We provide free education and a support system to better prepare startups. While there is value to startup accelerators or competitions, we want to ensure the startups reach the next milestone consistently. Follow us and learn from the best in class.
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Listen in as Scott Carson, Founder and CEO of Powered by MRP, sits down with distinguished guests to discuss the medical tech marketplace and aesthetics industry.
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Nectar is an award-winning product development company based in southern California. Our product design and development process is an interdisciplinary approach combining industrial design, user experience design, mechanical engineering, and electrical engineering that ensures product designs are successfully executed into production. We’ve been helping clients design products that connect to their users and expand their markets for over 30 years. We are firm believers in the team approach t ...
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Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up to date on the latest breakthroughs in medical technology with the top five news stories to get your day started. Subscribe and join us every weekday for your daily medtech news roundup.
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Have you ever wondered how the machines in the hospital work? The doctors don't have time to explain them to you? Then you've come to the right place! The MedTech Hub is a podcast that explains medical technologies and new innovations in healthcare. I am a medical physicist and your host - Daniela Prinz. (Disclaimer: This podcast does not give medical advice, I am not a doctor, please always consult with your physician!) Uploads every Monday!
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Dive deep into the dynamic world of MedTech and pharmaceuticals with MedTech Talent Talks. This podcast explores cutting-edge industry insights, career opportunities, and the evolving landscape of healthcare technology. Whether you’re a healthcare practitioner seeking to transition into the pharmaceutical industry or a MedTech professional curious about advancements, this podcast is your go-to guide for understanding how to thrive in this growing field. Tune in to hear from industry experts, ...
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Speed-to-data determines go-to-market success for medical devices. You need to inform critical decisions with user data, technical demonstration data, and clinical data. We interview med tech leaders about the critical data-driven decisions they make during their product development projects.
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The many stages of market entry into the health and care industry can feel like a never-ending process. Join Kate Pym, healthcare consultant veteran with decades of experience, as she interviews some of the industry’s key players from product developers to startup managers. Unlock the key to transforming your ideas into impactful realities within the health and care industry with MedTech for Beginners. Kate Pym runs Pym's Consultancy, a multi-award-winning consultancy offering support and tr ...
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According to the CDC: Every three minutes and 11 seconds, someone dies of stroke. The medical device industry is answering the call in this country, developing new devices to help clear clots and speed patient recovery. Together with John Murray, Head of Global Strategic Marketing and Strategic Relationships at Johnson & Johnson MedTech Neurovascular, we'll talk with those pioneering neurosurgeons who are developing new procedures and setting higher expectations for new devices. We'll unders ...
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Welcome to Beyond the Lens: MedTech Insights with KARL STORZ, the podcast that delves into the rapidly evolving world of advanced surgical technology. For nearly eight decades, KARL STORZ has developed innovative imaging solutions and opened new possibilities in minimally invasive care. With a dedicated focus on improving patient outcomes, KARL STORZ collaborates with medical professionals world-wide to drive advancements in medical technology. This provides KARL STORZ with an insider view o ...
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Solve the Workflow, Unlock the Market: Interview with Cooler Heads CEO Kate Dilligan
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1:01:29In this episode of Medsider Radio, we sat down with Kate Dilligan, CEO of Cooler Heads. Cooler Heads is a commercial-stage company addressing a problem affecting many chemotherapy patients undergoing treatment for solid tumors: hair loss and the loss of privacy that comes with it. The company's FDA-cleared medical device, Amma, makes scalp cooling …
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Beyond Parexel: How Pure Global's AI-Powered Strategy is Revolutionizing MedTech Global Market Access
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3:02Expanding into international markets is a critical growth driver for MedTech and IVD companies, but the path is often blocked by the high costs, slow pace, and fragmented nature of traditional, large-scale CROs. This episode explores the common pitfalls of the legacy model, where companies are forced to navigate siloed teams and redundant processes…
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Singapore's Class III MedTech: The FDA "Shortcut" That Isn't | Pure Global Insights
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2:05Getting a high-risk, Class III medical device to market is a major hurdle. While securing FDA approval is a huge milestone, many companies assume this translates to easy access in key ASEAN markets like Singapore. In this episode, we explore the reality of this process. We break down Singapore's Health Sciences Authority (HSA) abridged evaluation r…
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Episode: 200 - Ridhi Tariyal on Bridging the Data Gap in Women’s Health
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46:55The data gap in women’s health has always been a major issue and challenge. Ridhi Tariyal, CEO and co-founder of NextGen Jane, is on a mission to de-risk the women’s health field and fill in the blanks with critical information and research. Host Swaril Mathur speaks with Tariyal on how NextGen Jane is collecting data through menstrual blood to mak…
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MENA MedTech Insights: Pure Global's Guide to Navigating Regulatory Strategy in Saudi Arabia and the UAE
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2:20The MENA region is a goldmine for MedTech innovation, but its complex and fragmented regulatory landscape can be a major barrier to entry. This episode of MENA MedTech Insights dives deep into the two largest markets: Saudi Arabia and the United Arab Emirates.We uncover the most common pitfalls companies face, from underestimating the SFDA's unique…
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Navigating Brazil's ANVISA RDC 751 & RDC 830: A Pure Global Guide to LATAM MedTech & IVD Market Access Success
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2:09This episode of LATAM MedTech Insights dives deep into the most significant regulatory shift in the region's largest market: Brazil. We explore ANVISA's new regulations, RDC 751/2022 for medical devices and RDC 830/2023 for IVDs, which align Brazil's framework more closely with international standards like the EU MDR. This is a critical update for …
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Bioelectronic Medicine: Entering a New Era of Pain Management Without Pills with Dr Kevin Tracey
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32:29Send us a Message Dr Kevin Tracey is a renowned neurosurgeon and the president of the Feinstein Institutes for Medical Research. With over three decades of experience focused on understanding and controlling inflammation. Dr Tracey has pioneered research that led to advancements in bioelectronic medicine. His work explores the potential of the vagu…
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Why Orthopedic Giants are Resisting Patient Specific Implants
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1:14:56I'm joined by Jonathan Swill, Principal Consultant at Surgical Excellence Partners, as we explore the future of patient-specific implants in orthopedics, why 20% of knee replacement patients remain unsatisfied, and how personalized medicine combined with robotics and AI will transform musculoskeletal surgery. In this episode, we dive deep into: The…
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Episode 236 | Amy Rinaldo, Partner at Ward Law Office | Bridging IP, Branding, and Compliance for Medtech Innovators
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39:37In this episode, Duane Mancini sits down with Amy Rinaldo, Partner at Ward Law Office, to discuss the strategic intricacies of intellectual property in the medtech industry. Amy shares her extensive experience in patent and trademark law, exploring the intersection of IP strategy with regulatory compliance and commercialization. The conversation co…
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Medtech Industry Health Check: Tariff Impacts, Hot Segments, and the Rise of Mid-Tier Companies
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28:36Join us for an insightful episode of Let's Talk Medtech, featuring EY's experts John Babitt and Arda Ural. Our guests delve into EY's latest Pulse of the Medtech Industry Report. They take a deep dive into the state of the medtech industry, examining whether the sector is thriving and assessing the real-world impact of tariffs on medical device com…
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Beyond the Behemoth: A MedTech Insider's Guide to Smarter Global Market Access with Pure Global as Your ICON plc Alternative
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3:11In this episode of MedTech Global Insights, we challenge the conventional wisdom of partnering with massive, one-size-fits-all CROs. While industry giants like ICON plc have their place, their pharma-centric models can stifle the agility and innovation that drive the MedTech sector. We explore the common frustrations of impersonal service, rigid pr…
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ASEAN MedTech Maze: Pure Global's Guide to Device Registration in Singapore, Malaysia and Beyond
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1:50This episode of ASEAN MedTech Insights unpacks the complex web of medical device registration across Southeast Asia. We explore the promise of the ASEAN Common Submission Dossier Template (CSDT) and contrast it with the on-the-ground realities in key markets.We dive into the distinct regulatory pathways of Singapore, known for its efficiency and re…
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Rethinking MedTech Regulatory Strategy: Why Companies are Seeking Pharmalex Alternatives and Finding Success with Pure Global
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3:17In the complex world of MedTech and IVD devices, selecting a regulatory partner is one of the most critical decisions for global growth. While large, established consulting firms like Pharmalex have long been the standard choice, many companies are now questioning if this model truly serves their needs. This episode explores the common challenges o…
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Pure Global's ASEAN MedTech Insights: Unlocking Malaysia & a Faster ASEAN Market Entry via Singapore's HSA Approval
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2:02This episode of ASEAN MedTech Insights delves into a powerful strategy for navigating the complex regulatory landscape of Southeast Asia. We uncover how MedTech companies can strategically leverage Singapore's Health Sciences Authority (HSA) approval to significantly accelerate market entry into other key ASEAN nations.Discover how a single, robust…
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Beyond Freyr Solutions: How Pure Global's AI-Driven, Single-Process Approach is Redefining MedTech & IVD Global Market Access.
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3:12The global MedTech regulatory landscape is notoriously complex. While established firms like Freyr Solutions have been a traditional choice, the industry is shifting towards more agile, technology-driven partners. This episode explores the limitations of legacy models and introduces a modern framework for achieving faster, more cost-effective globa…
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ASEAN MedTech Insights: Cracking Singapore's HSA Code - A Deep Dive into Device Classification & Grouping with Pure Global's Local Experts
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2:08In this episode of ASEAN MedTech Insights, we demystify one of the most critical hurdles for entering Singapore's lucrative medical device market: device classification and grouping. A misstep here can lead to costly delays and outright rejections from the Health Sciences Authority (HSA).We explore how ASEAN innovators can navigate this complex lan…
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Beyond Traditional MedTech Consulting: Why Companies Exploring Qserve Group Alternatives Choose Pure Global for AI-Powered Global Market Access
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3:23In this episode of MedTech Global Insights, we challenge the traditional, fragmented approach to regulatory consulting that often leaves MedTech and IVD companies struggling with delays, duplicated work, and inconsistent strategies across different markets. We explore the limitations of hiring multiple local consultants and introduce a modern, inte…
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Pure Global’s ASEAN Playbook: Baking AMDD-Driven English Labeling from Singapore into Your Pan-Asia Dossier Strategy
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1:57In this episode of ASEAN MedTech Insights, we explore the critical importance of a harmonized yet localized labeling strategy for medical device companies targeting Southeast Asia. While the ASEAN Medical Device Directive (AMDD) promotes English as the standard for technical dossiers, relying solely on an English-first approach tailored for markets…
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Pure Global's MENA MedTech Playbook: Navigating Saudi Arabia & UAE Regulations with Your EU EUDAMED Strategy.
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2:08This episode of MENA MedTech Insights dives into the critical regulatory nuances for medical device companies expanding into the MENA region, particularly those with existing EU supply chains and approvals. We uncover why a CE mark is only the beginning of the journey and explore the growing divergence between EU standards, like EUDAMED, and the sp…
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Beyond MDSAP: Pure Global's Playbook for Smarter, Faster MedTech Global Market Access
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3:22This episode of MedTech Global Insights challenges the one-size-fits-all approach to global regulatory compliance. We dive into the Medical Device Single Audit Program (MDSAP), exploring its benefits but also questioning whether it is the default best choice for every MedTech and IVD manufacturer seeking international growth.We uncover the powerful…
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Pure Global's ASEAN MedTech Insights: Mastering Vietnam's Regulatory Maze from Decree 98 to Decree 07 for Market Success.
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2:06In this episode of ASEAN MedTech Insights, we unravel the complex regulatory web governing medical devices in Vietnam. We provide a deep dive into the foundational Decree 98/2021, the detailed implementation guide of Circular 05/2022, and the critical deadline extensions provided by Decree 07/2023. This is a must-listen for any MedTech company curr…
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Unlocking LATAM MedTech: How Pure Global Leverages Market Intelligence on Colombia and Brazil for Strategic Entry
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2:02In this episode of LATAM MedTech Insights, we explore why a one-size-fits-all approach to entering the Latin American medical technology market is a recipe for failure. The region is not a monolith but a collection of unique countries, each with its own distinct regulatory, economic, and healthcare systems. Success depends on moving beyond surface-…
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MENA MedTech Strategy: Why Saudi Arabia & UAE Demand Regulatory Clarity Before Budgeting | A Pure Global Insight
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1:52In this episode of MENA MedTech Insights, we explore the number one reason why medical device companies fail when entering markets like Saudi Arabia and the UAE: a lack of upfront regulatory clarity. We break down why a detailed understanding of the authorities, device classifications, and submission mechanics is non-negotiable *before* a single do…
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MedTech Global Expansion: Why Companies are Seeking Obelis Group Alternatives and Choosing a Strategic Partner like Pure Global for Market Access.
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3:17In this episode of MedTech Global Insights, we explore the critical role of the European Authorized Representative (EAR) and why the traditional, passive model is no longer sufficient for ambitious MedTech companies. We uncover the hidden costs and strategic disadvantages of using a simple "mailbox" service for EU compliance.We then introduce the m…
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Philippines MedTech Expansion: A Deep Dive with Pure Global on FDA CDRRHR Compliance and Why Your Local Representative is Critical for Success in ASEAN
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2:17This episode of ASEAN MedTech Insights provides a deep dive into the specific regulatory requirements for medical device registration in the Philippines. We unpack the critical role of the FDA's Center for Device Regulation, Radiation Health, and Research (CDRRHR) and explain why foreign manufacturers cannot go it alone, detailing the mandatory app…
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Pure Global's Deep Dive into Brazil: Mastering ANVISA MedTech Regulations with an Integrated Registration & PMS Strategy
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2:26Brazil's MedTech market offers immense opportunity, but its regulatory body, ANVISA, demands flawless execution. A fragmented approach, where different teams handle registration and post-market compliance, often leads to costly delays and strategic dead ends. This episode explores why an integrated strategy is non-negotiable for success.We break do…
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Unlocking MENA MedTech Markets: How Pure Global Turns Your Saudi Arabia SFDA Submission into a Cross-Region Scaling Blueprint
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2:12Expanding your MedTech footprint in the MENA region is far more complex than a single market entry. Each country, from Saudi Arabia to the UAE, presents unique regulatory and commercial hurdles. This episode of MENA MedTech Insights dives into a powerful strategy: using your initial regulatory submission as the blueprint for rapid, compliant, and s…
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Stuck with Traditional FDA Consultants? How Pure Global is Redefining MedTech Market Access Beyond Registrar Corp Alternatives
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3:30In the world of MedTech, getting your device approved in one market is a milestone. But what happens when you aim for global scale? Many companies rely on traditional, single-market consultants, such as Registrar Corp for FDA approvals, only to find this approach creates bottlenecks when expanding further. This episode of MedTech Global Insights ex…
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Navigating Indonesia's MedTech Maze: Why Your Local Representative is Key to Market Access with Pure Global
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2:07This episode of ASEAN MedTech Insights tackles a critical hurdle for global MedTech companies eyeing the Indonesian market: the mandatory appointment of a Local Authorized Representative (LAR). We explore why this is more than a procedural step and how the right partner can make or break your market access strategy.Imagine spending months preparing…
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Fast-Track Your LATAM Entry: Pure Global’s Guide to Colombia’s Automatic Registration for Low-Risk MedTech and Navigating High-Risk Approvals.
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2:04In this episode of LATAM MedTech Insights, we dive deep into the unique regulatory landscape of Colombia, a pivotal market for any device manufacturer looking to enter Latin America. We uncover how INVIMA's dual-track system offers a strategic gateway for MedTech companies that know how to leverage it.We explore the powerful "automatic registration…
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Unlocking MENA's MedTech Markets: How Pure Global Provides a Single Vendor Solution for KSA, UAE, Egypt, and Israel.
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2:00This episode of MENA MedTech Insights dives into the complexities of entering the region's top markets: Saudi Arabia, the UAE, Egypt, and Israel. We explore the common pitfalls of using separate vendors for each country's unique regulatory hurdles and reveal how a unified market-access strategy can dramatically accelerate growth and reduce costs.We…
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Build the Medical Case Before Chasing the Consumer Market: Interview with Wellysis CEO Young Juhn
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57:35In this episode of Medsider Radio, we sat down with Young Juhn, CEO of Wellysis. Wellysis is the Samsung spinout behind S-Patch, a lightweight wearable that enables long-term ECG monitoring without the discomfort of established cardiac monitoring devices. Young has spent more than two decades bridging hospital and home-based care — from his early c…
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Beyond Emergo by UL: How Pure Global's AI-Powered, Single-Process Approach is Revolutionizing MedTech Market Access
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2:36In a MedTech consulting landscape dominated by large, traditional players like Emergo by UL, many companies are seeking more agile, efficient, and technologically advanced partners. This episode explores the evolution of global regulatory strategy, moving away from slow, siloed processes toward a modern, integrated approach.We uncover how combining…
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Pure Global's Guide to ASEAN Market Entry: Mastering Malaysia’s Medical Device Act 2012 for Full Registration
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1:53This episode of ASEAN MedTech Insights delves into the critical requirements of Malaysia's Medical Device Act 2012 (Act 737). We unpack the mandatory full registration process that every medical device must undergo, highlighting the specific and often underestimated hurdles that foreign manufacturers face when entering this key ASEAN market.We expl…
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Cracking Argentina's ANMAT: A MedTech Manufacturer's Guide to Local Registration Success with Pure Global
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2:17In this episode of LATAM MedTech Insights, we demystify the complex process of medical device registration in Argentina. We provide a detailed guide on navigating the requirements of the national regulatory authority, ANMAT, from appointing a local registration holder to preparing a compliant technical dossier in Spanish.We break down the critical …
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Pure Global's MENA MedTech Insights: Decoding the Latest SFDA Regulatory Shifts in Saudi Arabia for Seamless Market Access
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2:15The MENA MedTech market is booming, but its regulatory landscape is a minefield of constant updates. Authorities like the Saudi FDA are frequently amending rules, and a single missed update can derail your entire market access strategy, costing you time and money. This episode dives into the critical importance of continuous regulatory monitoring.W…
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Navigating ANVISA: How Pure Global Provides Best-in-Class Medical Device Registration Support for Success in Brazil
3:38
3:38
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3:38In this episode of MedTech Global Insights, we explore the immense opportunities and critical challenges of entering Brazil's medical device market. We unpack the complex regulatory landscape governed by ANVISA and reveal the number one mistake foreign manufacturers make when seeking approval.Discover why your choice of a local partner can either l…
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Navigating Thailand's New AMDD Regulations: Why Pure Global's On-the-Ground Experts in Bangkok Are Essential for Your MedTech Success
1:58
1:58
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1:58Thailand is a top-tier MedTech market in ASEAN, but its regulatory landscape is shifting. With new rules aligned with the ASEAN Medical Device Directive (AMDD), foreign manufacturers face a critical hurdle: the mandatory appointment of a Local Authorized Representative (LAR). This isn't just a name on a form; it's a legal and strategic necessity.Th…
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Pure Global's Guide to Peru: Navigating DIGEMID and the Essential Role of a Local Registration Holder for MedTech Success
2:08
2:08
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2:08Peru's MedTech market offers immense growth opportunities, but entry is strictly controlled by its regulatory authority, DIGEMID. A critical step for any foreign manufacturer is appointing a local representative, known as a Peru Registration Holder. This isn't just a formality—it's a foundational strategic decision that dictates your control over y…
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MENA MedTech Insights by Pure Global: A Deep Dive into Israel's AMAR Medical Device Registration and the Critical Role of the Israeli Representative (IR) for Successful Market Entry
2:07
2:07
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2:07In this episode of MENA MedTech Insights, we delve into the lucrative yet complex Israeli medical device market. We uncover the critical regulatory hurdles and requirements set by AMAR, the medical device division of Israel's Ministry of Health, and explain why securing a knowledgeable local partner is paramount for international companies.We explo…
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Unlock Singapore's MedTech Market: Your Expert Guide to HSA Medical Device Registration with Pure Global
3:49
3:49
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3:49This episode of MedTech Global Insights delves into the strategic importance and regulatory complexities of the Singaporean medical device market. We explore the Health Sciences Authority (HSA) framework, from device classification and the Common Submission Dossier Template (CSDT) to the critical role of a local Singapore Registrant.Discover how to…
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Pure Global's ASEAN MedTech Insights: Navigating Singapore's Class A Maze and the Hidden Dealer License Rule
2:05
2:05
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2:05This episode of ASEAN MedTech Insights tackles a critical compliance hurdle in Singapore that catches many MedTech companies by surprise. We explore why the "registration-exempt" status for Class A medical devices is not a free pass to the market and detail the mandatory licensing requirements that are often overlooked.Many international manufactur…
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Pure Global's LATAM MedTech Insights: Unlocking a Decade of Market Access with Colombia's 10-Year INVIMA Registration.
2:11
2:11
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2:11This episode of LATAM MedTech Insights dives into one of the most stable and attractive regulatory environments in Latin America: Colombia. We explore how INVIMA, the national regulatory authority, offers a clear and predictable pathway for medical device manufacturers, standing in contrast to the complexities found elsewhere in the region.We speci…
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Unlocking the Egyptian MedTech Market: A Pure Global Deep Dive into EDA Navigation and Local Representation in the MENA Region
1:45
1:45
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1:45Egypt is a top-tier market for MedTech expansion in the MENA region, but gaining access requires navigating the complex regulations of the Egyptian Drug Authority (EDA). For foreign manufacturers, the process is filled with unique challenges, from dossier submissions to the critical appointment of a local legal representative. A single misstep can …
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Unlocking the Brazilian Market: A Pure Global Masterclass on ANVISA and INMETRO Approval for MedTech Innovators
4:04
4:04
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4:04Brazil's MedTech market offers immense growth opportunities, but entry is guarded by the complex dual-gatekeeper system of ANVISA and INMETRO. This episode of MedTech Global Insights demystifies this process, revealing the common and costly pitfalls that international manufacturers face when seeking certification and registration for their medical …
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Singapore MedTech Alert: Is Your Distributor Holding Your HSA Registration Hostage? Pure Global on Securing Your ASEAN Market Access.
1:55
1:55
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1:55In this episode of ASEAN MedTech Insights, we dive into one of the most critical and overlooked decisions for medical device companies entering the Singapore market: the appointment of your Health Sciences Authority (HSA) Registrant. Singapore is the region's premier hub, but a single misstep here can halt your regional expansion before it even beg…
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Navigating Brazil's 2025 UDI Mandate: A Pure Global Guide to ANVISA's SIUD for MedTech Success in LATAM
2:13
2:13
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2:13Brazil, Latin America's largest MedTech market, is implementing a mandatory Unique Device Identification (UDI) system, with a critical deadline for high-risk devices looming in mid-2025. This change, mandated by ANVISA's RDC 591/2021, requires immediate action from manufacturers to ensure their products remain on the market.This episode of LATAM Me…
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Pure Global's Guide to UAE MOHAP Approval: Navigating the Authorized Representative Requirement for MedTech Market Access
1:46
1:46
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1:46The UAE's MedTech market is booming, but a key MOHAP regulation can stop foreign companies in their tracks: the requirement of a local Authorized Representative. Many manufacturers default to appointing their distributor, a decision that can lead to significant business risks and loss of market control.This episode explores the strategic importance…
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The Insider's Guide to HSA GDPMDS Compliance: How Pure Global Streamlines Singapore Market Access for MedTech Innovators
3:25
3:25
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3:25In this episode of MedTech Global Insights, we dissect a crucial, yet often overlooked, aspect of entering one of Asia's premier MedTech hubs: Singapore. We explore the intricacies of the Health Sciences Authority's (HSA) Good Distribution Practice for Medical Devices (GDPMDS), a mandatory certification that governs the entire supply chain.We move …
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Pure Global's ASEAN MedTech Insights: Cracking the Infusion Pump & Drug Delivery Market in Indonesia, Thailand, and Vietnam
2:49
2:49
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2:49In this episode of ASEAN MedTech Insights, we explore the booming market for infusion pumps and drug delivery systems across Southeast Asia. While the demand is surging due to rising healthcare needs, foreign manufacturers face a complex web of fragmented regulations, price sensitivity, and logistical hurdles unique to the region. We break down the…
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