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Listen Medical Device Regulation and Standards
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TGA Capital Management provides the and shares proprietary investment research and investment strategies to successful individuals seeking financial unbiased guidance and we discuss the insight of benefits members can receive free without obligation as a subscriber of our podcasts, informative email alerts, website resources and the election to serve you as a fiduciary.
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Matthias from TGA speaks on all things Hip Hop. Support this podcast: https://podcasters.spotify.com/pod/show/trust-me-im-a-rapper/support
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Tower Talk highlights the best of Long Island by providing “all access” interviews with the NCC Foundation Business Leaders Council, top entrepreneurs, and local business owners who will discuss a range of topics that impact both owners and executives alike.
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The embodiment of The Guardian Academy can be summed up by these statements: Live to learn. Give to earn. Educating on how to become a Guardian of your own life through interactive experience and harnessing the power of community to help the diffusion of innovation and develop leadership. TGA focuses on helping to develop amazing humans and removing suffering using the power of Web3.
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Just 2 new dads living the gamer life 1 day at a time.
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At the age of 15, Geoff Keighley started a quest to create the ultimate awards show to honor his heroes: video game creators. Now, for the first time, Geoff shares the 20-plus year journey behind The Game Awards, the largest digital awards show in the world. Geoff and special guests take listeners behind the scenes of the business of making an independent awards show, including a sneak preview of what's in store for this year's Game Awards on December 7.
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Each week Steph Lowe speaks with experts from all over the world in the areas of nutrition, microbiome health, environmental sustainability, psychology, meditation and more. Together we’ll teach you the answers to becoming healthy, happy and a more conscious human, and why your contribution to the planet truly matters.
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Inside the Den is a podcast about connection and the human behind the community in the world of web3. Each week, you’ll hear from an array of extraordinary people building in the blockchain space. Including members and partners inside The Wolf Den - a web3 community of investors, business owners, and people aiming to do good in the world by sharing their stories of transformation and valuable insights on how to be a better human. Listening to this podcast will help you understand the power o ...
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Promoting the hard working individuals of our amazing cannabis community. We will stand together 🙏
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Join Mark, Irv, Craig and Tom every week as we discuss everything Film, TV and Comic related including a discussion of the most recent releases.
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Welcome to the Hidden Hueco Academy podcast! Co-hosted by Gallicide Ghoul, DiabolicHollow, and Frostytofu. on the Academy podcast we discuss anything from Music, Anime, Manga, Video Games, Entertainment, current news, and topics we think are interesting.
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Welcome to #TheGreyArea podcast, where five British Nigerian girls - Seyi, Ati, Mayowa, Jemine and Ope - candidly explore the intricacies of life's ‘grey areas’. From identity and culture clashes to relationships and career choices. Tune in every other Wednesday as we navigate the complexities of modern life with humor, honesty, and a unique perspective. Follow us on Instagram @tgapod for more behind-the-scenes content and to interact with us!
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Independent, not-for-profit and evidence-based, NPS MedicineWise provides practical tools and information about medicines, health conditions and medical tests to help individuals and health professionals make better health decisions.
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A podcast for the theater obsessed geek who also likes a side of true crime. We talk about Broadway flops, scandals and new work. "Who Fails, Who Sues, We Tell Their Stories"Part of the Broadway Podcast Network.
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A video game podcast focusing on Final Fantasy VII Remake! Each episode will concentrate on various aspects of the most anticipated game of all time. Join host Ky (Rob Pretty) and co-host Vyzz, creator of the Cosmo Canyon Observatory YouTube Channel, for featured discussions about interesting topics, recently released info/news, along with community interaction, interviews, and much more! Inquiries: thereunionpodcast@gmail.com
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HHHK 494: Using TGA-Approved Microbiome Testing for Personalized Gut Health Diagnosis and Treatment with Kirsty Wirth
42:20
42:20
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In today’s episode we are joined by Kirsty Wirth to discuss the latest developments in gut microbiome testing, including the shift from culturing to metagenomic testing, and the significance of TGA approval for these tests. We explore the importance of using meaningful diagnostic markers, such as calprotectin, to inform treatment decisions and brid…
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Ray Schwetz and Donyshia Boston-Hill get business empowerment from Dr. Moronke Oshin-Martin, owner and director of TGA (Tennis, Golf and Athletics) Premier Sports of Northern Nassau County. They grow the sports kids love and enrich the lives of children through at-school sports programs.By 90.3 WHPC
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Cassandra Jones - Financial Professional and Master Artist
28:21
28:21
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28:21
Ray Schwetz gets business empowerment from Cassandra Jones, Financial Professional and Master Artist. Cass brings a unique set of skills to each one her clients. Now mastering the art of finance, she has joined the mission of empowering the world with financial education. Her passion and her driving force has always been helping others and making c…
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HHHK 495: Parenting in a Changing World The Importance of Connection, Self-Love and Being Present with Kim Morrison
45:51
45:51
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45:51
In today’s episode we are joined by Kim Morrison to discuss parenting in a changing world: the importance of connection, self-love and being present. We start with a reflection of the pandemic on our lives and communities, emphasizing the importance of connection and resilience. We then discuss the challenges and rewards of parenting and grand-pare…
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Registration of Medical Devices can be complicated. But here we will share with you the process for the United Arab Emirate where the famous city of Dubai is located. Ahmed Hendawy from Registitute is helping us to understand this process and he confirms that it is really simple. So no way that you miss this. Who is Ahmed Hendawy? Ahmed is an estee…
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Cerebral Palsy Association of Nassau County
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Ray Schwetz and Donyshia Boston-Hill get business empowerment from Chris Feehan, the Development Assistant at Cerebral Palsy Association of Nassau County. Chris is also the Long Island Events Coordinator for the Empire City Garrison of the 501st Legion, which Star Wars fans know to be the charitable side of Star Wars fandom.…
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More and more regulations have to be applied in parallel of the EU MDR and the one of the EU Battery Regulation is not an exception. Erik Vollebregt from Axon Lawyers will be explaining to us what are these additional requirements. He will also confirm that Notified Bodies can ask you questions about it and finally he will share some key timelines …
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HHHK 493: Wayne Holdsworth of SmackTalk Turning Personal Grief into a Movement for Suicide Awareness
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In today’s episode we are joined by Wayne Holdsworth to share with you his personal story of tragedy and now, activism. This episode discusses suicide so please only continue listening today if it feels right for you. We discuss suicide and the need for increased awareness and action regarding mental health challenges and suicide prevention. We cov…
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You are working with a Software that contains an AI/ML algorithm then you should listen to this podcast episode and understand the requirements of the AI ACT to your medical device. Fabien Roy, lawyer will explain to us what are the challenges that he has identified for medical device manufacturers working with Artificial Intelligence. Who is Fabie…
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Medboard EU Germany warns against overregulation of Medical Devices – Is it not too late: https://www.bundestag.de/presse/hib/kurzmeldungen-1006422 Title: MDR and IVDR next steps – Subtitle: Erik Vollebregt points: https://medicaldeviceslegal.com/2024/06/04/the-german-angle/ MDCG 2022-13 Rev1 – Extension of the scope of designations: https://health…
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HHHK 492: Understanding Metabolism and Weight Loss for Women in Mid-Life with Joe Hoye
42:58
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In today’s episode we are joined by Joe Hoye from Hoye Fit. Joe shares with us his personal journey from insecurity to fitness enthusiasm and coaching and what inspired his upcoming online summit, 'Midlife Makeover Summit’. We share with you weight loss challenges in midlife, emphasising the need for a holistic approach that considers metabolic hea…
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Ray Schwetz and Donyshia Boston-Hill get business empowerment from Lee'Ann Burgess, Founder of Social Vibe Marketing. Lee'ann has over 15 years of experience in business-to-business marketing, e-commerce, and sustainable business practices. She has also been recognized in an elite group of one of only 55 LinkedIn certified marketing experts globall…
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HHHK 491: Uncovering the Root Causes of IBS Through Holistic Testing and Treatments, Finding a Sustainable Work-Life Balance and Supporting Digestive Health with Nourished Blends with Lynsey Koch
45:15
45:15
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In today’s episode we are joined by Lynsey Koch, Nutritionist from Seed & Sprout Nutrition. Lynsey and I discuss holistic approaches to digestive health, including stress management, advanced testing methods and the significance of circadian rhythm in maintaining a healthy gut microbiome. We explore the challenges of balancing work and family life,…
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You don’t know what a regulator will say when seeing your AI/ML Software, then listen to this episode. Richie Christian will explain the important elements that you should take care off before to submit your dossier to your Notified Body or your Competent Authority. So enjoy. Who is Richie Christian? Richie Christian has more than 10 years of exper…
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HHHK 490: Male Infertility, Factors at Play, Testing + How to Optimise Male Fertility for Conception with Steph Lowe
46:02
46:02
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46:02
In today’s episode Solaine Douglas interviews me on all things male fertility and hormones. We discuss the need for a more comprehensive approach to male fertility diagnostics and treatment, emphasizing the importance of including men in the fertility conversation from day one. We explore comprehensive male hormone assessments and individualised su…
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2 Gamer Dads Episode 34: The Game Show Episode
1:49:42
1:49:42
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Happy Father's Day to all Dads and Dads to be! The Gamer Dads are back on twitch, this time with quad-Dads on the show including a newly minted one! #2gamerdadsBy 2GamerDads
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If you are looking for selling your medical devices in Europe, you will then maybe need a Notified Body unless your product is class I. In this episode, we talk with Thomas Lommatzsch about the process of designation and why it is so difficult. We will also cover some questions regarding the auditors, the costs, the audit by the competent authoriti…
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Ray Schwetz and Donyshia Boston-Hill get business empowerment from Ellen Smiley, who works as a self-employed Financial Literacy Coach.By 90.3 WHPC
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HHHK 489: Understanding Teens - Athletes, RED-S, Low Iron & More with Kira Sutherland
44:04
44:04
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In today’s episode we are joined by Kira Sutherland, to discuss teens - athletes, RED-S, low iron and more. Kira shares with us the primary reasons teens come to work with her and the positive relationship between nutrition and athletic performance rather than it solely being about body composition or aesthetics. We explore RED-S - Relative Energy …
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Have you ever had to deal with Cleaning Validation. If yes than you know the pain to select the instruments and group them and for each group find a worst case. On this episode, we tell you how this should be working so you can guarantee to provide clean products and clean instructions to your customers. Who is Heena Thakkar? Heena Thakkar is a reg…
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HHHK 488: Hypothalamic Amenorrhea, Ovulation, Fasting & More with Steph Pearson
43:21
43:21
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In today’s episode we are joined by Steph Pearson to discuss the complex relationship between hormonal imbalances and nutrition, particularly in relation to reproductive health. We highlight the causes and consequences of hormonal imbalances, including hypothalamic amenorrhea, the importance of menstrual cycle tracking, the potential impact of bioh…
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Ray Schwetz and Donyshia Boston-Hill get business empowerment from Aditya Varanasi, CEO of Awarity, an affordable and sustainable digital marketing solution from up-and-coming companies, making world-class marketing more affordable without sacrificing quality.By 90.3 WHPC
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EUROPE EU MDR 26 May 2024 – Was there any apocalypse: France: https://ansm.sante.fr/actualites/reglement-europeen-relatif-aux-dispositifs-medicaux-fin-de-la-periode-de-transition Netherland: https://www.igj.nl/zorgsectoren/medische-technologie/nieuws/2024/05/23/fabrikanten-van-medische-hulpmiddelen-moeten-uiterlijk-26-mei-een-aanvraag-hebben-ingedi…
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HHHK 487: Is it Really ADHD? with Kirsty Wirth
51:22
51:22
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In today’s episode we are joined by Kirsty Wirth from Kultured Wellness to explore the recent surge in ADHD diagnoses. We discuss the importance of understanding and managing your symptoms through routines, boundaries and sleep, while addressing root causes such as overstimulation and imbalanced cerebellum function. We discuss the effects of excess…
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TGA: How we Met + ‘I don’t think I was a coon…’- S1:E3 | #TheGreyArea.
1:20:53
1:20:53
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Join us on todays episode as we discuss whether kids are on the table, share stories of how we met and reflect on questionable decisions we made in school! If you’ve ever wanted to know more about our past lives this is the episode you don’t want to miss! Thanks for joining us for another episode of TGA! Stay connected with us on Instagram @tgapod …
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I am sure that when we talk about usability, you are not really sure what should be done. Usually we are also following a standard for that which is IEC 62366. On this episode, Amandine Broussier will specifically focus on one part of usability which is the Summative Evaluation. She will explain what this is and when it should be done. So listen to…
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Ray Schwetz and Donyshia Boston-Hill get business empowerment from Patricia Chambers Daly, the Senior Director of Development at Hour Children, Inc. Hour Children helps incarcerated and formerly incarcerated women and their children successfully rejoin the community, reunify with their families, and build healthy, independent, and secure lives.…
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HHHK 486: Fertility, IVF & the Vaginal Microbiome with Holly Sinclair
50:52
50:52
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In today’s episode we are joined by Holly Sinclair, a fierce advocate for women’s health and wellness., who helps women (and men) overcome seemingly insurmountable obstacles to conceive. We talk about preconception and male factor fertility issues, semen analysis, functional testing, our challenges with the term “unexplained infertility” and tradit…
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Do you have to manage complaints, CAPA, Non-conformances, audits, management reviews… for your company. Then you need to put in place actions. Today we will explain to you with Vincent Cafiso what are Correction, Corrective Actions and Preventive Actions. Who is Vincent Cafiso Named as one of MD+DI’s 24 Medtech Voices to Follow in 2024, Vincent Caf…
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Ray Schwetz gets business empowerment from Patrice Trelles, Executive Director of HR at Impact Learning Centers. Impact Learning Centers provides high-quality academic programs to families and educational institutions, positively impacting minority student success.By 90.3 WHPC
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HHHK 485: What’s New in Microbiome Testing with Rachel Larsson
58:12
58:12
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In today’s episode we are joined by Rachel Larsson to explore what’s new in microbiome testing. We look specifically to CoBiome and their new dream tests, MetaXplore GI and MetaXplore GI Plus, tests that many practitioners including myself have been waiting for, for many years. You will learn the importance of metagenomic sequencing, the functional…
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TGA: ‘He Threw a Bag of Tools at Me’- S1:E2 | #TheGreyArea.
1:09:00
1:09:00
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On this episode we discuss the search for community, work woes, crazy story times and chime in on the infamous man vs bear debate. Thanks for joining us for another episode of TGA! Stay connected with us on Instagram @tgapod for exclusive content and updates. We appreciate your support and can't wait to dive into more intriguing topics in our next …
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Medical Device manufacturers can also involve third party companies to manufacture their devices. We call them Contract Manufacturers. But they are only your supplier and not the legal manufacturer of the product. So now the question is how to select them and also how to handle them. Let’s find that out with Keith Smith from Vonco Who is Keith Smit…
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Ray Schwetz and Donyshia Boston-Hill get business and community empowerment from Victoria Catoir and Taylor Murray, Campaign Development Managers at the Leukemia and Lymphoma Society, a non-profit dedicated to creating a world without blood cancers. Since 1949, they have invested more than $1.7 billion in groundbreaking research, pioneering many of…
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HHHK 484: 'What's My Body Telling Me' with Dr Anthea Todd
38:31
38:31
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In today’s episode we are joined by Dr Anthea Todd, women's health practitioner and Chiropractor, with a little bit of spice. Anthea is the author of the recently released 'What's My Body Telling Me?' and today we explore your symptoms, how your body is the solution, not the problem, the four fundamentals of women’s health - nervous system, metabol…
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Michael Israel from Zuper.co is helping us understand the world of Field Service and then we can understand better how some information collected by Field Service Engineer can help Quality Department to have a better operation. Collect machine performance, train technicians, identify issues. Michael will also talk about Zuper which is a FSM softwar…
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Ray Schwetz gets business empowerment from Josh York, Founder and CEO of Gym Guyz. Gym Guyz is an in-Home & On-site Fitness Training Provider located in over 150 locations across 30 states, and 3 countries.By 90.3 WHPC
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EU Notified Bodies TUV SUD Denmark under MDR –Welcome to the Brother or Sister: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=150a0abbc0d4397086d648963fc940a321e02c11&group=NOTIFICATION&download=true AFNOR 46th NB under MDR –Finally a second one for France: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies…
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