To be human is to fail – period. And not just to fail once, but to fail a lot. As the author Samuel Beckett said: “Fail again. Fail better.” This saying means a lot to me and my family – so much so that my daughter got a tattoo of it. Why are we, and so many others, so deeply concerned by failure? And if it’s something we all do so often, why are we so afraid of it – especially those of us here in win-at-all-costs America? In this podcast, I sit down with successful, thoughtful people like B ...
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Chen Podcasts
Will Chen音樂創作,適合運動.休閒.開車.小憩.騎車～歡迎聆聽分享～ 請我喝杯咖啡,讓我持續創作,謝謝 https://pay.firstory.me/user/willchen-music Buy me a cup of coffee: https://pay.firstory.me/user/willchen-music Powered by Firstory Hosting
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When They Was Fab: Electric Arguments About the Beatles
Ed Chen and Jon Stone, Lonnie Pena, Martin Quibell
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Talk, more talk, chat, more chat - We’re happy to do it for you (Beatles)
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😴Are you suffering from Zoom fatigue? 💍Is engagement your #1 problem on virtual? 👩🏾🏫Do you want to lead the most engaging virtual meetings? 👂🏽Then you want the Engaging Virtual Meetings Podcast, the sure-fire, latest podcast on how to thrive on virtual. 📖Hosted by the #1 Amazon Hot-New Release author of Engaging Virtual Meetings, John Chen.
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Good Things from Lemonada Media is a podcast about the good people in the world who are rolling up their sleeves and working hard to make things better. Each week, we'll be talking about this country's most complex and confounding issues in an effort to affect systemic change, with a rotating cast of incredible guests and Lemonada hosts. From the dire condition of the American foster care system to the decline of Diversity, Equity and Inclusion initiatives, protecting democracy, and more, we ...
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David Chen and Patrick Klepek discuss everything going on in the world of TV, with recaps and reviews of the most interesting shows on the air. Hosted on Acast. See acast.com/privacy for more information.
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Insights into the latest clinical and research studies in orthopaedics. A podcast from JBJS, featuring Antonia Chen, MD, and Andrew Schoenfeld, MD
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Different hosts, different topics, sometimes featured guests: but always about loving Meher Baba in the present tense. Conversations are held live on Baba Zoom at various times. If you want to join the conversation, visit babazoom.net for more information, login information is available under the ”Virtual Meetings” page.
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homework Cover art photo provided by Nahil Naseer on Unsplash: https://unsplash.com/@nahilnaseer
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In Season Two of SEQUESTERED, we step into the shadows of six cold cases involving missing or murdered individuals whose stories have yet to be brought to justice. These cases don’t begin with crime scenes—they begin in the quiet, everyday moments that suddenly turned tragic. Through victim-centric, time-capsule storytelling, SEQUESTERED brings life to stories long buried in silence. New episodes drop on Mondays. Subscribe on Apple Podcasts for exclusive bonus episodes and content! Because s ...
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In The Filmcast, hardcore geeks David Chen, Devindra Hardawar, and Jeff Cannata debate, pontificate, and delve into the latest films, TV shows, and other entertainment-related items from the past week. Weekly guests include everyday bloggers, webmaster luminaries, film directors, and movie stars from all walks of life. You can reach us at [email protected] and find more podcast episodes at www.thefilmcast.com
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Redeeming Truth is a podcast from the pastors and leaders at Redeemer Bible Church in Gilbert Arizona. In a world where theological error and a low view of God is rampant in the church, the pastors of Redeemer Bible Church call us back to the truth by diving deep into scripture.
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A seasonal show about nostalgia and novelty – an exploration of embracing the evolution. genxtaste.substack.com
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Like the popcorn topping that inspired the name, The Extra Buttery Podcast is an often salty, but oh-so-appropriate addition to your movie, TV and pop culture experience. You'll hear Jason and Robert discuss and quarrel over the latest casting news, project announcements, and trailers. You'll hear reviews of films and TV shows both new and old, and maybe some special guests. Extra Buttery uploads monthly, so follow the show and let us know what you think!
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Join psychic surgeon Andy Porter as he channels his spirit guide Chen to explore deep spiritual protection, energy healing, and the magic of the unseen realms. Each episode offers grounded guidance, powerful insights, and transformational conversations for those walking a conscious path.
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New Media Cover art photo provided by Autumn Studio on Unsplash: https://unsplash.com/@autumnstudio
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音樂河是創作人：陳偉益的原創音樂天地~ 適合 : 放鬆.睡眠.休閒.閱讀.靈修.餐敘.運動....等 請我喝杯咖啡,讓我充滿靈感持續創作,謝謝 https://pay.firstory.me/user/musicriver Piano Music Relaxing and Meditation: Will Chen Music, It is suitable for precipitating the mind, helping sleep, spiritual thinking, and meditation. Buy me a cup of coffee: https://pay.firstory.me/user/musicriver Powered by Firstory Hosting
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Welcome to Betty Chen, where amazing things happen.
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People political positions Cover art photo provided by Jonathan Simcoe on Unsplash: https://unsplash.com/@jdsimcoe
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Welcome to the Boldin Podcast — your trusted source for retirement planning, financial wellness, and purposeful living. Formerly known as NewRetirement, Boldin is on a mission to empower you to take control of your financial future. Whether you're nearing retirement, already retired, or just starting to plan, we cover what matters most: money, lifestyle, health, meaning, and how to retire smarter. Each episode features expert interviews and actionable insights on topics like retirement incom ...
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One Jewish guy, one Chinese guy. We are roommates living in NYC. We rambled on Some random topics. I know, no one listens. But, who cares??!!
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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 Gavin Chen, where amazing things happen.
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Welcome to Kenneth Chen, where amazing things happen.
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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 the Kingsley Chen podcast, where amazing things happen. Cover art photo provided by Ricardo Gomez Angel on Unsplash: https://unsplash.com/@ripato
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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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ETC 3301 Rocks in Spring 2019! Cover art photo provided by Christian Perner on Unsplash: https://unsplash.com/@christianperner
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Vet Sessions is a Canadian veterinary medical podcast based out of Guelph, Ontario. This podcast is for anyone interested in learning more about small animal veterinary clinical medicine and especially primary care. Follow along with Dr. Omar Khan, Dr. Shannon Gowland, and Dr. Tiffany Durzi as they tackle common clinical questions and dissect what it means to be a primary care veterinarian. Podcast produced by Sherry Lin. Podcast artwork by Michelle Lai, Sammie Wu, Andrea Wanlin Jia, and Shi ...
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Welcome to Yulin Chen, where amazing things happen.
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Capturing once in a lifetime moment and each encounter is one of a kind and unique. Life designer is looking to genuine and meaningful human connection, and telling candid human stories. In each episode, I will interview an amazing talent coming from all around the world across all different industries. They are artists, creatives, professionals, entrepreneurs, slash everything, and they are all on their journey to pursue their mission with a passion. It's their story-telling about how they ...
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Welcome to the Tina Chen podcast, where amazing things happen. Cover art photo provided by Jeremy Galliani on Unsplash: https://unsplash.com/@jeremyforlife
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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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Tai Chi
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ENG4U Synthesis : Jiayi Chen
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Life, Experiences, and Adventures with a 22 year old trying to survive their twenties.
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Let the arrows fly is a podcast that talks about homeschooling and Christian parenting.
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In every single episode, Aaron Chen gives his listeners ONE simple idea that they can use to potentially make thousands in their business and life!
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Podcast by Tiffany Jade Chen
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Billion Dollar Moves™ with Sarah Chen-Spellings | Global Venture Capital
Sarah Chen-Spellings
9159
Lead, build, and invest better. Join us as we hit the streets globally to uncover billion dollar ventures of unicorn founders & funders. In venture, every move can make—or break—a billion-dollar outcome. Hosted by Sarah Chen-Spellings, award-winning entrepreneur, investor, and venture insider, Billion Dollar Moves pulls back the curtain on the strategies, stumbles, and breakout moments that define the world’s most iconic companies. From boardroom power plays to investor backchannels, you’ll ...
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How to make your hard-earned cash work for you.
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Funboat Diplomacy is a show hosted by Weimin Chen. Guests come from a variety of backgrounds and discuss their lives back home, experiences in other countries, and share their perspectives.
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Simple Ways to WOW Your Clients Every Day with Jeff Borschowa
49:29
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Jeff is a visionary entrepreneur, accomplished author, passionate educator, and dedicated coach, committed to empowering forward-thinking business owners on their journey to exponential growth. With an impressive 33-year career spanning the realms of business, accounting, and coaching, Jeff has consistently delivered groundbreaking Client Acquisiti…
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Andy Porter Psychic Surgeon, trance channels his spirit guide "Chen" in this podcast explore the profound yet often overlooked role of caregivers, both family and professional, and how they can protect themselves mentally and spiritually while serving others. Caregiving includes tending to loved ones with dementia or chronic illness, as well as wor…
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My Self-Portrait of Dopamine — Survive in Innate Duality and Thrive in Inherent Paradox
52:55
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This episode is an intimate exploration of my dopamine-driven nature—how it fuels my intrinsic motivation, creative pursuits, and relentless drive for refinement. I unpack the paradox of thriving in long-term, effortful passion projects while still wrestling with distraction, novelty, and fleeting dopamine hits. From cultivating exquisite attention…
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read～Will Chen音樂創作,適合運動.休閒.開車.小憩.騎車～歡迎聆聽分享～ 請我喝杯咖啡,讓我持續創作,謝謝 https://open.firstory.me/join/willchen-music Buy me a cup of coffee: https://open.firstory.me/join/willchen-music 留言告訴我你對這一集的想法： https://open.firstory.me/user/cl52kftlw06dp01t9dqzz933n/comments Powered by Firstory Hosting
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Cracking the Brazil Code: How Pure Global's Expert Consultants Streamline ANVISA Registration for MedTech Innovators
3:31
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Brazil's MedTech market offers immense opportunities, but ANVISA's complex and demanding regulatory process can be a major barrier to entry. This episode of MedTech Global Insights demystifies the path to ANVISA approval, moving beyond simple compliance to reveal a strategic approach for success.We delve into the critical role of a specialized regu…
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Pure Global Presents: Your Strategic Roadmap to Medical Device Licensing in Indonesia & ASEAN - Demystifying MOH Regulation No. 62 of 2017
3:29
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This episode of ASEAN MedTech Insights provides a deep dive into the essential requirements of Indonesia's Minister of Health Regulation No. 62 of 2017. We break down the critical pillars for medical device registration, including the mandatory appointment of a local license holder, the four-tier risk classification system, and the meticulous docum…
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Navigating Chile's Technovigilance Maze: A Pure Global Breakdown of Resolution 1618/2020 for MedTech Market Access in LATAM
3:51
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In this episode of LATAM MedTech Insights, we provide a detailed analysis of Chile's Resolution Exenta No. 1618/2020, a landmark regulation that established a strict technovigilance framework for medical devices. We dissect the specific reporting obligations, mandatory timelines, and the critical role of the in-country legal representative.This ses…
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Unlocking the Israeli MedTech Market: Pure Global's Expert Guide to AMAR Medical Device Law and Strategic Registration Requirements for MENA Expansion
3:14
3:14
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In this episode of MENA MedTech Insights, we demystify the process of registering medical devices in Israel. We explore the strategic advantages of the AMAR Medical Device Law of 2012, which leverages prior approvals from recognized countries like the U.S. and the E.U. to create a streamlined market-entry pathway.This episode breaks down the essent…
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Unlocking Southeast Asia: Why Pure Global is Your Key to Medical Device Registration Success in Singapore.
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Singapore stands as the premier gateway to the booming MedTech market of Southeast Asia. However, its rigorous regulatory framework, managed by the Health Sciences Authority (HSA), can be a significant barrier for even the most innovative companies. This episode breaks down the essential steps and common pitfalls of medical device registration in S…
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Late Night Chat with Jeff Wolverton: E&G: Giving our Interior to Baba, Sep 21, 2025, live Baba Zoom
1:23:27
1:23:27
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We have some informal chat after every arti, the "post-arti party"! But once a week, Jeff Wolverton joins us for some serious mining of the spiritual depths. Join us for conversation, more readings, songs, quotes - you never know what treasures will be uncovered! Dear folks of Baba, Around 1970, a buddy of mine and I were visiting a college mate of…
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EP 178 | Has Wokeness Gone Underground in the Church? | Redeeming Truth
58:38
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Is wokeness dead in the church, or has it simply gone underground? Join pastors Kyle Swanson, Todd Burgett, Virgil Walker, Jason Stinson, and Darrell Harrison from Redeemer Bible Church as they tackle one of the most debated issues of our time. In this episode of the Redeeming Truth Podcast, the panel explores the evolution of wokeness, its impact …
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Pure Global's Guide to Singapore's MedTech Regulations: Unlocking ASEAN Market Access Through Technical Specifications
3:05
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In this episode of ASEAN MedTech Insights, we demystify the core technical specifications required under Singapore's Health Products (Medical Devices) Regulations 2010. We explore why Singapore serves as a crucial launchpad for the broader ASEAN market and break down the specific documentation demands of the Health Sciences Authority (HSA).We delve…
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Pure Global's MedTech Guide: Mastering Brazil's ANVISA RDC 497/2021 for Your Device Registration and GMP Certification Update
3:32
3:32
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In this episode of LATAM MedTech Insights, we dissect the crucial updates to Brazil's medical device regulations, specifically ANVISA's RDC 497/2021 and the recent amendment RDC 850/2024. We explore how these resolutions have fundamentally changed the administrative process for obtaining and renewing the essential Brazilian Good Manufacturing Pract…
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Cracking the Code of Egypt's EDA Decree 892/2022: A Pure Global Guide for MedTech Success in the MENA Market
3:20
3:20
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This episode of MENA MedTech Insights unpacks the transformative impact of the Egyptian Drug Authority's (EDA) Decree 892/2022 on medical device registration. We explore the critical changes manufacturers must understand to successfully navigate one of the region's most important healthcare markets.From the alignment of risk classifications with gl…
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Unlocking Brazil's MedTech Market: A Pure Global Insider's Guide to Navigating ANVISA and Mastering Medical Device Registration
3:20
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This episode of MedTech Global Insights tackles the complex but rewarding process of medical device registration in Brazil. We explore why Brazil's ANVISA is one of the world's most challenging regulatory bodies and break down the critical strategic decisions companies must make to succeed, from selecting a Brazil Registration Holder (BRH) to adapt…
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Cracking the Code of Thai FDA Approval: Pure Global's Expert Insights on Complying with Thailand’s Medical Device Act B.E. 2551 for ASEAN MedTech Innovators.
3:06
3:06
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This episode of ASEAN MedTech Insights unpacks the essential steps to comply with Thailand’s Medical Device Act B.E. 2551. We explore the Thai FDA's risk-based classification system, the different registration pathways available to foreign manufacturers, and the critical role of a local authorized representative.Navigating this landscape is challen…
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Pure Global's Guide to UAE MedTech Marketing: A Deep Dive into MoHAP's Circular No. 23 of 2020 for Market Success in the Emirates.
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In this episode of MENA MedTech Insights, we take a deep dive into the United Arab Emirates' stringent regulations for medical device advertising. We unpack the essential framework established by the Ministry of Health and Prevention's (MoHAP) Circular No. 23 of 2020, a critical piece of legislation for any MedTech company operating in or entering …
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David, Devindra, and Jeff discuss the enormous cultural impact of the late Robert Redford, settle off shore with Eden, look back at fascist Italy in Mussolini: Son of the Century, and try to get a late check-out with Haunted Hotel. Then they sprint to the endzone to give their thoughts on Him. We're making video versions of our reviews! Be sure to …
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Sahavas for Everyone: guest Naosherwan Nalavala, Sep 17, 2025 live on Baba Zoom
1:13:09
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Sahavas for Everyone. First and third Wednesday of the month. Avatar Meher Baba is in each one of us. And His Love is the focus of this gathering. Open discussion with each session having a topic or theme. Hosted by Laurent Weichberger in SC. Guest Naosherwan Nalavala Jai Baba! This event was recorded live. To be first to be notified of a new video…
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America is experiencing a maternal health crisis. We are witnessing the worst maternal death rate for Black mothers amongst developed nations. Shawnee Gibson is ensuring we don't forget the women behind the numbers. She lost her daughter to a pulmonary embolism a few weeks after giving birth and has been fighting for reproductive justice with her o…
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Searching for the Best Medical Device Regulatory Consultant Near Me? Why Pure Global's Global Reach is the Local Expertise You Need.
3:50
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In this episode of MedTech Global Insights, we tackle a critical question for every ambitious medical device company: How do you find the "best" regulatory consultant? We challenge the traditional idea of a "local" partner and explore why, in today's interconnected world, the ideal consultant is one with global reach and deep-rooted local expertise…
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How Steve Burns Found His Aliveness Again
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Steve Burns is best known for being the host of a beloved 90s children’s show, Blue’s Clues, so I didn’t expect this interview to be about Samuel Beckett. But it turns out that Steve and I share a deep admiration for the writer, as well as a lot of other common ground. Steve went quiet for about two decades after rumors of his death took over the i…
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Navigating Malaysia's Medical Device Act 737: An ASEAN MedTech Insight for 2025 Compliance with Pure Global's Expert Analysis
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This episode of ASEAN MedTech Insights dives deep into the current implementation status of Malaysia's Medical Device Act 737. We move beyond the basics of initial registration and explore the new era of stricter enforcement that all MedTech manufacturers must navigate. We discuss the critical updates from the Medical Device Authority (MDA) and wha…
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Unlocking the Colombian MedTech Market: A Pure Global Expert Guide to Medical Device Registration under Decree 4725 of 2005
3:09
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This episode of LATAM MedTech Insights offers a detailed guide to registering your medical device in Colombia, focusing on the foundational regulation, Decree 4725 of 2005. We break down the essential requirements set by Colombia's regulatory authority, INVIMA, providing manufacturers with a clear roadmap for successful market entry into one of Lat…
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Unlock the UAE MedTech Market: Pure Global's Expert Breakdown of Cabinet Decision No. 58 of 2022 for MENA Compliance
3:12
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In this episode of MENA MedTech Insights, we dissect the UAE's transformative Cabinet Decision No. 58 of 2022. This new regulation is a critical hurdle for any MedTech or IVD company looking to enter or remain in this key Middle Eastern market. We provide a clear, actionable breakdown of the most significant changes you need to be aware of.We explo…
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Episode 135 - "The cat was probably the star of the movie." [CAUGHT STEALING feat. Marina Bennett]
1:01:00
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In the 135th episode of The Extra Buttery Podcast, Jason and Robert reunite in Vancouver once again and welcome back special guest Marina Bennett to discuss Darren Aronofsky's newest film CAUGHT STEALING. Austin Butler stars as washed-up baseball prospect caught up between rival gangs. But does Matt Smith steal the show? Are Liev Schreiber and Vinc…
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S5E2 Reflections on Failing then Passing the NAVLE with Dr Nicole Iarusci
24:54
24:54
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Join Dr Shannon Gowland as she chats with OVC Graduate Dr Nicole Iarusci. Nicole shares her insights about the challenging experience of failing the NAVLE exam, finding the support and inspiration to start studying again and the approach she used to pass on her second attempt. It is a reassuring listen for anyone who has worried about failing the e…
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Mastering MedTech Compliance: How Pure Global Redefines ISO 13485 and ISO 14971 Consulting for Global Success.
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This episode of MedTech Global Insights delves into the critical challenges of maintaining ISO 13485 (Quality Management Systems) and ISO 14971 (Risk Management) compliance while scaling into global markets. We move beyond the basics of certification and explore why a fragmented, market-by-market approach to regulatory compliance is no longer viabl…
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Lots of funny costumes this month, as George, Eric, Neil, the Splinter Boys, Hall and Oates all hang out together. They are joined by Macca, Spinal Tap, news concerning Paul's additional tour dates, Ringo talking about Mae West (but not her sweaty vest), and others!By Ed Chen and Jon Stone, Lonnie Pena, Martin Quibell
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Pure Global Presents: Mastering the ASEAN CSDT for MedTech Success in Singapore, Malaysia, and Vietnam
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This episode of ASEAN MedTech Insights dives deep into the complexities of the ASEAN Common Submission Dossier Template (CSDT). We move beyond the checklist to uncover the unwritten rules and nuanced expectations of regulators in key markets like Malaysia, Vietnam, and Indonesia. Learn why a one-size-fits-all approach fails and how specific, locali…
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LATAM MedTech Insights by Pure Global: Mastering Argentina's ANMAT Renewal Under Disposition 2318/2002 to Secure Your Market Access.
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In this episode of LATAM MedTech Insights, we demystify the seemingly simple but highly nuanced process of renewing medical device registrations in Argentina. We take a close look at the specific requirements outlined in ANMAT's Disposition 2318/2002, focusing on the critical 90-day submission deadline and the legally binding "sworn declaration."We…
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Navigating SFDA's UDI Maze: A Pure Global Guide to Medical Device Compliance in Saudi Arabia and the MENA Region
3:17
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In this episode of MENA MedTech Insights, we provide a deep dive into the Saudi Food and Drug Authority's (SFDA) Unique Device Identification (UDI) system. We explore the critical requirements of guidance MDS-G34, a non-negotiable for medical technology companies operating in Saudi Arabia, a key market in the Middle East. Understanding this framewo…
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Unlocking Global SaMD Success: A Deep Dive into Choosing the Best Regulatory Consultant with Pure Global's AI-Powered Approach
3:34
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In this episode of MedTech Global Insights, we explore the unique and complex regulatory landscape of Software as a Medical Device (SaMD). As SaMD innovation accelerates with AI and machine learning, navigating the fragmented global regulations from the FDA to the EU MDR and beyond has become a primary barrier to market access. We dissect what sepa…
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Unlocking ASEAN MedTech Markets: Pure Global's Deep Dive into the AMDD for Singapore, Thailand, and Vietnam
3:17
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In this episode of ASEAN MedTech Insights, we explore the ambitious ASEAN Medical Device Directive (AMDD). Designed to create a harmonized, single market for medical devices across ten nations, the AMDD promises streamlined access and unified standards. We break down its core requirements, from the four-tier risk classification system to the crucia…
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Pure Global Presents LATAM MedTech Insights: Mastering Mexico's NOM-241 GMP for Medical Device Manufacturing Success
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This episode of LATAM MedTech Insights provides a detailed analysis of Mexico's mandatory Good Manufacturing Practices (GMP) standard, NOM-241-SSA1-2021. We explore the critical requirements for medical device manufacturers, importers, and distributors operating in Mexico, focusing on the pillars of a compliant Quality Management System (QMS), risk…
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Pure Global's Expert Guide to Saudi Arabia's MDMA: Secure Your MedTech Market Access in the MENA Region with the Interim Regulation
3:04
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This episode of MENA MedTech Insights dives deep into the Saudi Arabian medical device market, focusing on the most critical pathway for international manufacturers: obtaining a Medical Device Marketing Authorization (MDMA) through the SFDA's Interim Regulation. We unravel the process, clarifying how leveraging approvals from key global markets can…
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『獨舞』鋼琴創作,適合睡眠.居家.休閒.靈修.放鬆.默想.(Nature,relaxing music,spirituality,meditation,reading,breakfast
1:41:31
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『獨舞』鋼琴創作,適合睡眠.居家.休閒.靈修.放鬆.默想. 請我喝杯咖啡,讓我充滿靈感持續創作,謝謝 https://open.firstory.me/join/musicriver Welcome to spotify to listen to my music creation 歡迎到spotify聆聽我的音樂創作 https://open.spotify.com/artist/1RLCg0WtgWNvTJuOyADcVk?si=_p5rbWDzRBmsY7CfdWcG9w 留言告訴我你對這一集的想法： https://open.firstory.me/user/ckno4lbqwsxh60816t7xaopk7/comments Powered by Firstory Hosting…
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Unlocking the UAE MedTech Market: How Pure Global Masters MOHAP Medical Device Registration
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The United Arab Emirates is a top-tier market for MedTech and IVD devices, but entry is strictly controlled by the Ministry of Health and Prevention (MOHAP). In this episode, we explore the common pitfalls and hidden complexities of the MOHAP registration process that often derail even the most experienced manufacturers.We break down the critical s…
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Ep. 82 - The Test of a Free Society (Plus: Entering the Endgame of 'Alien: Earth' and 'Peacemaker')
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In this episode of the Decoding TV podcast, David and Patrick discuss what’s going on in the world of TV, then dive into the latest episodes of Alien: Earth and Peacemaker. What do we make of the (probable) cancellation of Jimmy Kimmel? Is Peacemaker just spinning its wheels these days? Will Alien: Earth end up being the show that was promised at t…
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Cracking the Code: Pure Global's Expert Guide to Licensing AI Medical Software for Import into Thailand's Booming ASEAN MedTech Market.
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This episode of ASEAN MedTech Insights unpacks the specific regulatory process for importing and licensing AI-based medical software in Thailand. We explore the Thai FDA's unique requirements, including the crucial "Efficiency Review" for all AI and machine learning technologies, and provide actionable advice for manufacturers looking to enter this…
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Cracking the Code of Mexican MedTech: Pure Global's Guide to NOM-137-SSA1-2008 Labeling for LATAM Success
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In this episode of LATAM MedTech Insights, we explore the intricate details of Mexico's medical device labeling standard, NOM-137-SSA1-2008. As one of Latin America's largest MedTech markets, Mexico presents a huge opportunity, but access is strictly controlled by its regulatory body, COFEPRIS.We break down the most common mistakes foreign manufact…
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Cracking the Code to Saudi Arabia's MedTech Market: A Pure Global Deep Dive into SFDA MDS-G5 Technical Documentation Requirements
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This episode of MENA MedTech Insights offers a deep dive into the technical documentation required by the Saudi Food and Drug Authority's (SFDA) MDS-G5 guidance. We break down the critical components of a successful technical file submission, from device descriptions and risk management to clinical evaluation reports, for MedTech and IVD companies …
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Unlocking Brazil's MedTech Market: Your Expert Guide to ANVISA Registration with Pure Global
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Brazil is a top-tier market for MedTech and IVD innovation, but its regulatory agency, ANVISA, presents one of the world's most challenging approval pathways. This episode of MedTech Global Insights dives deep into the complexities of Brazilian market entry, moving beyond theory to offer practical, actionable strategies for success.We explore the c…
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Cracking the Code: A Pure Global Deep Dive into Risk Classification for Predictive AI Software in Malaysia and ASEAN
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The rise of AI in diagnostics is revolutionizing healthcare, but for MedTech innovators, it presents a complex regulatory challenge. In the key ASEAN market of Malaysia, the risk classification of your predictive software is the single most important factor determining your path to market, influencing everything from cost and timelines to the requi…
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LATAM MedTech Insights: A Pure Global Guide to Brazil's INMETRO Ordinance 384/2020 for Medical Device Compliance and Market Access
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In this episode of LATAM MedTech Insights, we demystify the mandatory INMETRO certification for electro-medical devices in Brazil. We break down the critical requirements of Ordinance 384/2020, a regulation that serves as a vital gatekeeper to one of Latin America's most significant markets. We'll guide you through the conformity assessment process…
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Navigating SFDA's AI Maze: Pure Global's Expert Insights on Updating Your Registered Medical Software in Saudi Arabia & the MENA Region
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In this episode of MENA MedTech Insights, we delve into a critical challenge for innovators: how to manage updates for AI-powered medical software that is already registered with the Saudi Food and Drug Authority (SFDA). The iterative nature of AI development clashes with rigid regulatory frameworks, creating a significant hurdle for manufacturers.…
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