Les meilleurs podcasts Tga (2024)

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What are the TOP 3 issues on CAPAs?

2d ago

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in this episode, Georg Digel will help use solve 3 major problems with our CAPAs. He will tell you what these problems within your Quality Management System are and propose some solution. We will also talk about the education of the team. Who is Georg Digel? I’ve reviewed too many Medical Device CAPAs over the last 10 years. I think I’ve seen almos…

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Medical Device News, October 2024 Regulatory Update

10d ago

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Medboard: https://www.medboard.com/ EUROPE TEAM NB – Code of Conduct for NB – Version 5: https://www.team-nb.org/wp-content/uploads/2024/09/PressRelease-CoC-20240916.pdf TEAM NB – IVDR Transition – Transition to the implementation of Class D oversight by EURLs: https://www.team-nb.org/wp-content/uploads/2024/10/PressRelease-ClassD-20241001.pdf MDCG…

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How to select the best plastic for your Medical Device?

17d ago

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In this episode, Lucas Pianegonda will help us to select the right material for your medical device and also answer questions that you maybe would love to hear his answer. We will also talk about sustainability for plastics. So check this. Who is Lucas Pianegonda? Lucas Pianegonda is an expert for medical grade plastics, material testing and materi…

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UK vs EU vs US – How to switch to another region easily?

26d ago

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In this episode, Claire Dyson will give us the recipe to launch correctly your Medical Device when you go abroad and for that we will take the example of EU and US. Who is Claire Dyson? Who is Claire Dyson? Claire Dyson began her career in rational drug design and moved into medical device through devices that interact with drugs and drug-delivery …

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Episode 115: ZENDA 1:02:44

1M ago1:02:44

1:02:44

Come on, this podcast isn't about novels...its about BROADWAY! But as Pamela likes to say, A good story is a good story, is a good story!". And this story was first told in the form of a novel. If you want to know more, you'll have to listen to the story i the form of a podcast:) Learn more about your ad choices. Visit megaphone.fm/adchoices…

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How to do a PMCF Literature Search for Medical Devices?

1M ago

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In this episode, Cesare Magri will try to improve our skills on PMCF literature search. We will investigate on the misconceptions and what people should make to do it right. Who is Cesare Magri? Cesare Magri is the founder and CEO of 4BetterDevices GmbH. He and his team of medical doctors and biostatisticians assist medical device and in-vitro diag…

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Episode 114: Memorial For Chita Rivera and Angela Lansbury 1:32:15

1M ago1:32:15

1:32:15

Ebony and Pamela eulogize the life and accomplishments of these remarkable ladies of stage and screen. They were incredible, and have left a black hole in their wake! Learn more about your ad choices. Visit megaphone.fm/adchoicesPar Broadway Podcast Network

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Medical Device News, Septembre 2024 Regulatory Update

1M ago

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EU e-IFU for medical devices – Consultation ongoing: https://ec.europa.eu/eusurvey/runner/Survey_eIFUs_medicaldevices_2024?surveylanguage=EN MDR Transition period – Visual timeline: https://health.ec.europa.eu/document/download/06bb3982-dc01-46aa-95af-d8833c9fcb21_en?filename=timeline_mdr_en.pdf Implementing Act IVDR Common specifiaction – Consulta…

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Episode 51: Quit smoking. What makes a difference? 37:45

1M ago37:45

37:45

Smoking is still the leading cause of preventable death. Prioritising the conversations, providing support and using Quitline can make all the difference.Find the transcript here: www.nps.org.au/podcast/episode-51-quit-smoking.-what-makes-a-differenceFurther readingQuit Centre www.quitcentre.org.auQuitline www.quit.org.au…

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How to use AI GPT for your Quality and Regulatory work?

1M ago

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In this episode, Martin King will share with us his practice of AI in the context of Quality and Regulatory affairs for medical devices. This will explain to you some best practices to maintain to avoid some pitfalls. Who is Martin King? Martin Cranston King, a Swiss consultant working with medical devices, in vitro diagnostics (IVD), and pharmaceu…

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REPOST Episode 35: PRETTYBELLE 1:49:16

2M ago1:49:16

1:49:16

GEEKS...we have a special guest this episode! His name is Robby, and he's really funny, and cool, and he really likes theatre. And yes folks, you heard that book title correctly! Yowsers! Learn more about your ad choices. Visit megaphone.fm/adchoicesPar Broadway Podcast Network

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TGA: ‘Her Child Sh*t on me’ + Hairstylist Horror Stories - S1:E5 | The Grey Area 1:48:19

2M ago1:48:19

1:48:19

In our first official visual episode, we share hair stylist horror stories and reveal some of our unpopular opinions. 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 episode!…

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How to go from Zero to Hero in Medical Devices?

2M ago

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In this episode, Stephen O’Rourke that was not working within the Medical Device industry will share with us is journey from Zero knowledge in the field to running projects. Listen to his journey in case you are also willing to breakthrough the medical device field. Who is Stephen O’Rourke? Stephen O’Rourke, based in Berlin, Germany, is a seasoned …

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Episode 113: TRUCKLOAD 44:09

2M ago44:09

44:09

Ebony pulls this double wide story right into the gas station of our collective minds! It's a truck metaphor...or is that a semi-truck metaphor?...ha! But Pamela, why?! You all knew what you were getting yourselves into when you opened the podcast app, and clicked on mine and Ebony's cartoon faces. So no pumping the brakes now. Lets go the full int…

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Manage the Transfer/Renewal/Surveillance/Change of your CE certificate

2M ago

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In this episode, I have invited Ralf Gansel to help us understand the process for Certification of your product and what is the lifecycle for it. We’ll discuss about Transfer or certificates, or notification of changes or why there is a renewal and not continuous surveillance… Who is Ralf Gansel? With over a decade of experience in the medical heal…

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Episode 112: DUDE (THE HIGHWAY LIFE) 54:15

2M ago54:15

54:15

Pamela drowns the listener in details on this episode about Dude (the Highway Life), written by the same creative team who brought us Hair. Though that's where any comparisons may stop. This is a part of our Adela Holzer series, so make sure to listen to Episode 111 beforehand, to make sure you're all caught up! Learn more about your ad choices. Vi…

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How to use Harmonized Standards for Medical Devices?

2M ago

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Medical Devices should follow some standards but if these standards are harmonized this brings them to another level. This will be a great discussion with Beat Keller on how to use them correctly. Who is Beat Keller? Beat Keller is the founder and Managing Director of SMDC which supports medical devices to bring compliant medical devices on market …

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TGA: DLTMALTA + Can Men and Women be friends - S1:E4 | #TheGreyArea 1:22:19

2M ago1:22:19

1:22:19

After a long hiatus, we're back! In today's episode, we share our thoughts on DLTMALTA and discuss whether men and women can truly have a platonic relationship. 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 …

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IVDR Class D – Lesson learned from Notified Bodies

2M ago

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The EU IVDR is in place and we will focus on this episode on Class D devices. Andreas Stange will explain to us what TÜV SÜD learned from the 100th class D certificates they issued. We will also review the timeline for IVDR and explain the next deadline which is in October. So be aware of it now. Who is Andreas Stange? Dr. Andreas F. Stange is a vi…

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Episode 111: Adela Holzer - From Broadway Angel to Mistress of Manipulation 1:25:04

3M ago1:25:04

1:25:04

Ebony tells the story of Adela Holzer the lead Producer of the notorious musical Senator Joe. Adela Holzer became a fascinating character after we completed our episode of Senator Joe during the first season of the podcast. Since Pamela and Ebony are also both true crime junkies and that is one of the things that got them to begin this podcast, we …

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REPOST Episode 20: SENATOR JOE 42:06

3M ago42:06

42:06

Ebony details a musical based on Senator Joe McCarthy...Don't worry, Pamela was as confused as you probably are. It'll be fun though! Learn more about your ad choices. Visit megaphone.fm/adchoicesPar Broadway Podcast Network

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EU MDR Major update: Interruption or Discontinuation of supply!

3M ago

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The EU MDR is still not stable. There are still updates ongoing so stay tuned and listen to Erik Vollebregt explaining the Article 10a that will be integrated to the EU MDR where medical device manufacturers have to inform about interruption of supply. So what will be the requirements and what should you do. Listen to it to know more. Who is Erik V…

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How to register your Medical Device in the UAE?

3M ago

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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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EU Battery Regulation – How to be ready?

3M ago

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More and more regulations have to be applied parallel to the EU MDR and the one of the EU Battery Regulation is not an exception. Erik Vollebregt from Axon Lawyers will explain these additional requirements to us. He will also confirm that Notified Bodies can ask you questions about it and finally, he will share some key timelines for its implement…

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AI Act – What are the challenges for Medical Devices?

3M ago

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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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Medical Device News, July 2024 Regulatory Update

4M ago

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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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How to submit your AI/ML SAMD the right way?

4M ago

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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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2 Gamer Dads Episode 34: The Game Show Episode 1:49:42

4M ago1:49:42

1:49:42

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! #2gamerdadsPar 2GamerDads

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AFNOR – How is a Notified Body designated?

4M ago

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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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Cleaning Validation – How to select the worst case?

4M ago

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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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Medical Device News June 2024 Regulatory Update

5M ago

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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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TGA: How we Met + ‘I don’t think I was a coon…’- S1:E3 | #TheGreyArea. 1:20:53

5M ago1:20:53

1:20:53

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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Summative Evaluation – Common mistakes

5M ago

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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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Are you more Corrections or Corrective Actions or Preventive Actions?

5M ago

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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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TGA: ‘He Threw a Bag of Tools at Me’- S1:E2 | #TheGreyArea. 1:08:47

5M ago1:08:47

1:08:47

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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How to select and evaluate your Contract Manufacturer?

5M ago

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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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Quality Field Service for Medical Devices

6M ago

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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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Medical Device NewsMAY 2024 Regulatory Update

6M ago

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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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Intro to #TGA: ‘I’m not afro anything b*tch’ - S1:E1 | #TheGreyArea. 1:44:12

6M ago1:44:12

1:44:12

Welcome to #TGA! In our debut episode, we delve into what "TheGreyArea" means to us. Join us as we discuss Afrobeats, Birthday Makeup, Relationships, and more! Get ready for candid conversations and unfiltered perspectives on #TGA! Thanks for joining us for another episode of TGA! Stay connected with us on Instagram @tgapod for exclusive content an…

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Why and how to build a Quality Culture?

6M ago

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A quality culture seem to be a nice to have. But after listening this podcast episode with Lesley Worthington, you will see that it is worth to build one. We will review the description of a quality culture and how to build it. But also if this is required by a regulation and how you can align it with your compliance duties. Check this and share it…

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What is the impact of AI Act on Medical Devices?

6M ago

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The AI Act or Artificial Intelligence Act is now a reality. But what does it mean for the Medical Device industry and what should you do within your Quality or Regulatory affairs activities. Erik Vollebregt, from Axon Lawyers will tell us what we should understand with this new legislation and what are the consequences for the Medical Device commun…

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Radiation Sterilisation Master File (ISO 11137 & 11607)

6M ago

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If your products need to be sterilized, then you will need to prove that the sterilization process is validated and continues to work all through the life to the product. So Adam Isaacs Rae will provide you with the information on Radiation Sterilization requirements. Standards, guidelines, pitfalls. All this will help you remain compliant. Who is …

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Medical Device News April 2024 Regulatory Update

7M ago

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Sponsor: Medboard: https://www.medboard.com/ EU MDR and IVDR national languages update – France accepts English MDR: https://health.ec.europa.eu/document/download/aa9760e3-c864-4173-8b16-d790dac66d74_en?filename=md_sector_lang-req-table-mdr.pdf IVDR: https://health.ec.europa.eu/document/download/1e312d8f-8b34-45da-a5fa-1918ba618aca_en?filename=md_s…

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How to benefit from Surveys to build Clinical Evidence?

7M ago

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Since EU MDR and IVDR launched, there is a phenomenon that raised which is the use of surveys to gather clinical data. So we wanted to share with you how to do this right and what you should be careful on. So listen to Cesare Magri from 4BetterDevices who will tell us more about surveys in the Medical Device field. Who is Cesare Magri? Cesare has a…

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Engage the field and Enter the Arena 1:07:58

7M ago1:07:58

1:07:58

Resources Mentioned: Important Links (Follow/Join/Subscribe to Stay Updated): ► Website: https://www.GuardianAcademy.io/ ► Twitter: https://twitter.com/TheGuardianAcad ► Substack: https://knowledge.guardianacademy.io?r=2l20si To learn more about what the members and community is doing in both the real world and in web3, check out our friends over a…

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How to do Postmarketing Surveillance the right way?

7M ago

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The EU MDR and IVDR is a bit more demanding on Postmarketing Surveillance. In this episode we will explain to you from the eye of an auditor what they want to see and how you can avoid some mistakes that are always identified. Who is Steve Curran? Dr Steve Curran has over 20 years experience in the medical device industry both as an engineer and le…

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Learn more about FDA QMSR alignment with ISO 13485

7M ago

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The FDA announced the alignment of QMSR to the ISO 13485 standard. So now the question is: What does it change for me? Do you need to update your full QMS? Will you need to go through another audit or inspection? Is this really a revolution? Naveen Agarwal from Exceed will answer this question. So don’t miss this episode to know more about QMSR. Wh…

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Medical Device News March 2024 Regulatory Update

8M ago

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EU EU proposal to prevent shortage – And other things: https://www.consilium.europa.eu/en/press/press-releases/2024/02/21/medical-devices-council-endorses-new-measures-to-help-prevent-shortages/ Notified Body Survey – Interesting statistics: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_…

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New EU Proposal – EUDAMED, IVDR & Shortage

8M ago

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In January 29th, 2024, the EU Commission issued a Proposal that discuss mainly the shortage of Medical Devices, the EUDAMED availability and the IVDR transition periods. So apparently this is urgent and needed to avoid shortage. Let’s ask Erik Vollebregt what he thinks about it. Will this really help and when will this become a law as it is only a …

1
Will EtO gaz become a Medical Device?

8M ago

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When you are willing to sterilise your Medical Devices, you maybe think of EtO or Ethylene Oxyd as the method. So if you are on that case, there is a potential change that will happen and we want to alert you about that. Christina Ziegenberg from BVMed is answering my questions and will explain to us the situation. So don’t miss this episode. Who i…

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