Medical Device δημόσια
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Medical Device Insights

Prof. Dr. Christian Johner

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Der Podcast "Medical Device Insights" des Johner Instituts wendet sich an Medizinproduktehersteller, Behörden und Benannte Stellen. Er liefert Praxistipps, um sichere und wirksame Medizinprodukte mit minimalem Aufwand zu entwickeln, zu prüfen, zuzulassen und im Markt zu überwachen. Damit hilft er Herstellern, Audits sicher zu bestehen und mit ihren Produkten im Markt erfolgreich zu sein. Mit diesem Podcast sind die Hörerinnen oder Hörer bestens informiert und diskutieren mit Behörden, Benann ...
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We help medical device professionals deepen their knowledge of customers, the industry, and their role. Our main objective is to help you become expert in your current position, and through a better understanding of others within your company and the best practices in others in the industry, enable you to fast-track your career.
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The Medical Devices Group is the medical device industry hub that connects you with experts cherry-picked among our 350,000 members. • MedicalDevicesGroup.net – 1,000+ archived discussions + resources • medgroup.biz/premium – direct access to medical device experts • medgroup.biz/10x – in-person events • medgroup.biz/linkedin – legacy group • medgroup.biz/podcast – this podcast • medgroup.biz/eavesdrop – sister podcast Medical device work saves and transform lives, so we make our recordings, ...
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Website: https://www.newtomedicaldevicesales.com Break into Medical Device Sales Online Course: https://courses.newtomedicaldevicesales.com Guide for Breaking into Medical Device Sales Ebook: https://www.newtomedicaldevicesales.com/product/guide-for-breaking-into-medical-device-sales First Year in Ebook: https://www.newtomedicaldevicesales.com/prod…
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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 …
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Wer wann wofür bei Medizinprodukten haftet Die EU bereitet eine neue Produkthaftungsrichtlinie vor, die insbesondere Medizinproduktehersteller betrifft, explizit auch solche, deren Produkte Verfahren der künstlichen Intelligenz (KI) verwenden. Prof. Johner klärt im Gespräch mit dem auf Medizinprodukte und Produkthaftung spezialisierten Rechtsanwalt…
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In this episode of the Global Medical Device Podcast, host Etienne Nichols delves into the world of medical device quality and reliability with expert guest Kevin Becker. They explore the nuanced challenges of ethical decision-making in the MedTech industry, the complexities of accelerated testing, and the continuous quest for quality improvement. …
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Take a trip to 2004 for a moment. Yahoo was the #1 website on the planet. Mark Zuckerberg came up with Facebook. 14-year-old Taylor Swift signed on with Sony to pursue her career in country music. And from Stephen and Sarah Perry's perspectives, the Life Science industry was in desperate need of improvement. There was a lot of bureaucracy and red t…
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Website: https://www.newtomedicaldevicesales.com Break into Medical Device Sales Online Course: https://courses.newtomedicaldevicesales.com Guide for Breaking into Medical Device Sales Ebook: https://www.newtomedicaldevicesales.com/product/guide-for-breaking-into-medical-device-sales First Year in Ebook: https://www.newtomedicaldevicesales.com/prod…
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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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Was Sie vor, während und nach FDA-Inspektionen tun sollten, um einen FDA-Warning-Letter möglichst zu vermeiden Wenn sich die FDA zu einer Inspektion ankündigt, steigt der Blutdruck in den Unternehmen. Falls die Inspektion nicht erfolgreich verläuft, ist der Stress sogar noch höher. Der FDA-Experte Luca Salvatore gibt im Gespräch mit Prof. Johner Ti…
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Website: https://www.newtomedicaldevicesales.com Break into Medical Device Sales Online Course: https://courses.newtomedicaldevicesales.com Guide for Breaking into Medical Device Sales Ebook: https://www.newtomedicaldevicesales.com/product/guide-for-breaking-into-medical-device-sales First Year in Ebook: https://www.newtomedicaldevicesales.com/prod…
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In this episode of the Global Medical Device Podcast, host Etienne Nichols dives into the art of pitching to medical device investors with Blythe Karow, COO at Neurogeneces. Blythe shares her wealth of experience, from her early days as a marketer to leading significant product launches and achieving FDA breakthrough designations. The conversation …
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You are maybe about to take a new job and you find out this episode of the podcast on how to prepare for an interview. I must say that we have invited the expert in recruitment for Medical Devices Elena Kyria from Elemed. She will give you all the hints, tips to make your interview a success. So don’t miss this episode and don’t forget to raise you…
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Website: https://www.newtomedicaldevicesales.com Break into Medical Device Sales Online Course: https://courses.newtomedicaldevicesales.com Guide for Breaking into Medical Device Sales Ebook: https://www.newtomedicaldevicesales.com/product/guide-for-breaking-into-medical-device-sales First Year in Ebook: https://www.newtomedicaldevicesales.com/prod…
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In this episode of the Global Medical Device Podcast, Etienne Nichols is joined by Kavetha Ram, a seasoned expert in health and pharmaceutical sciences and the regulatory department leader at Spectra Medical Devices. Together, they delve into how new regulatory affairs professionals can get started in a career of medical device regulations and the …
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EU Transition to the IVDR and EUDAMED Roll Out -An extension? Never !!!!!: https://health.ec.europa.eu/system/files/2024-01/mdr_in-vitro-proposal.PDF Measures: https://ec.europa.eu/commission/presscorner/api/files/document/print/en/ip_24_346/IP_24_346_EN.pdf Question and Answers: https://ec.europa.eu/commission/presscorner/api/files/document/print/…
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Was die EU beschlossen hat und welche Chancen es gibt, sich "herauszuwinden" Der EU Data Act ist in Kraft getreten. Ab September 2025 müssen Organisationen seine Anforderungen erfüllen. Doch welche Organisationen betrifft der Data Act? Müssen Medizinproduktehersteller dessen Anforderungen einhalten? Oder gibt es Argumente und Konstellationen, die v…
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Break into Medical Device Sales Online Course: https://courses.newtomedicaldevicesales.com/yt/ Guide For Breaking into Medical Device Sales Ebook: https://newtomedicaldevicesales.squarespace.com/ New to Medical Device Sales Podcast: https://podcasts.apple.com/us/podcast/new-to-medical-device-sales/id1522512043 New to Medical Device Sales YouTube: h…
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In this episode, Etienne Nichols and guest Ashkon Rasooli explore the transformative impact of AI in the medical device industry. From AI-driven diagnostics and wearable health monitors to the future of surgical robots, they delve into how these technologies are reshaping healthcare. The discussion also touches on the challenges and opportunities i…
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We always have a problem to contact regulators to ask them if our strategy is correct. In Europe, you cannot do that with a Notified Body unless you apply with one first and they cannot provide you with advice but just agree or disagree on your plan. Is it the same with the FDA. They have a specific pathway called Q-sub or Pre-Submission and you’ll…
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Break into Medical Device Sales Online Course: https://courses.newtomedicaldevicesales.com/yt/ Guide For Breaking into Medical Device Sales Ebook: https://newtomedicaldevicesales.squarespace.com/ New to Medical Device Sales Podcast: https://podcasts.apple.com/us/podcast/new-to-medical-device-sales/id1522512043 New to Medical Device Sales YouTube: h…
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Who is Adam Isaacs Rae? Chartered quality professional with a Master’s Degree focused in Strategic Quality Management from University of Portsmouth. Demonstrated history of working aerospace & defence, medical device and the construction industry. Skilled in Operations Management, Lean Six Sigma, Failure Mode and Effects Analysis (FMEA), Value Stre…
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In this episode, I discuss a common question I get all the time: "Do I need an internships to break into medical device sales?" I talk on my thoughts and what I've personally happen in the real world. Break into Medical Device Sales Online Course: https://courses.newtomedicaldevicesales.com/yt/ Guide For Breaking into Medical Device Sales Ebook: ht…
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In this episode, we delve into the complexities and essentials of quality and regulatory roles in the medical device industry. Our esteemed guest, Jennifer Mascioli-Tudor, CEO and founder of JMT Compliance Consulting, shares her wealth of experience from top MedTech companies, underscoring the importance of proactive quality management, project man…
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Medica 2023 was really a great event and I am please to provide you here with a summary and interviews with multiple actors. You’ll see that this is so diverse. We met with Startups, Service Providers, Notified Bodies and asked them the questions you would like to ask. So don’t miss this opportunity first to understand what is MEDICA and second to …
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Dave Rosa is CEO of NeuroOne Medical Technologies, a company that has developed high-definition, minimally invasive diagnostic and treatment devices based on a unique thin film electrode technology, with an initial focus on epilepsy and the fast-growing neurostimulation market. In this episode he shares some times when tough feedback helped him gro…
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The EU MDR 2017/745 was extended but does this change something for you? Do you need to apply to your notified body later? What can be the promise made by your Notified Body? Can they advice you? Pritam from TÜV SÜD will be answering my question without any taboo. So don’t hesitate also to go to the show notes and see his details as at the end of t…
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Today I have the pleasure of sitting down with one of my students, Alex Spicer, to discuss his journey from being a loan officer to breaking into medical sales after attending the New To Medical Device Sales course.Break into Medical Device Sales Online Course:https://courses.newtomedicaldevicesales.com/yt/ Guide For Breaking into Medical Device Sa…
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In a today's conversation on the Global Medical Device Podcast, host Etienne Nichols engages with Dr. Maria Nyakern on the burgeoning integration of AI in medical devices. They delve into the European AI Act, discussing its impact on innovation and the critical role of trustworthy systems in clinical research. The episode also touches upon the chal…
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Medboard Who is Medboard Medboard: https://www.medboard.com/ EU EU Reference laboratories EURL EU Reference laboratories for IVD products: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302713 Article : https://health.ec.europa.eu/latest-updates/designation-eu-reference-laboratories-high-risk-vitro-diagnostic-medical-devices-2023-1…
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Sustainability isn’t a buzzword - it’s a crucial aspect of the mission within medical device and combination product design and manufacturing. But it’s not always easy to figure out all the design considerations that make products cost efficient, sanitary, AND sustainable. So how can we do it as an industry? Today, Cormac O’Prey, Principal and Dire…
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Break into Medical Device Sales Online Course: https://courses.newtomedicaldevicesal… Guide For Breaking into Medical Device Sales Ebook: https://newtomedicaldevicesales.squar… New to Medical Device Sales Podcast: https://podcasts.apple.com/us/podcast… New to Medical Device Sales YouTube: / @newtomedicaldevicesales Medical Sales Network Effects Pro…
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In this insightful episode, Eric Henry and Etienne Nichols delve into the evolving landscape of AI in MedTech, focusing on regulatory compliance and the future of AI in medical devices. They discuss the role of the FDA, FTC, and other regulatory bodies, and explore the implications of AI in product development and quality assurance. Quotes "We're s…
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This presentation was recorded during MEDICA COMPAMED 2023. Stefan Bolleininger from Be on Quality did share with us the information about HEATMAP for Regulatory Affairs. The idea is mainly to be able to improve the visualisation of a certain state of your department or project. There will be the collection of data, the scoring, then the creation o…
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Today I have the pleasure of sitting down with my good friend and colleague David Rawaf to discuss the differences of surgery and Medical Device Sales in the UK compared to America Break into Medical Device Sales Online Course: https://courses.newtomedicaldevicesales.com/pod/ Guide For Breaking into Medical Device Sales Ebook: https://newtomedicald…
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Easy Medical Device has its podcast and many other Quality and Regulatory Affairs people are also doing podcasting. I have met with Claudia and Jorg who are also having a podcast and we reviewed our experience and encouraged people to also start their podcast. Check our experience and learn from it. Who is Monir El Azzouzi? Monir El Azzouzi is the …
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Wanted to share tips that you could start doing to help you break into medical device sales, have success in it, as well as have success in life! Break into Medical Device Sales Online Course: https://courses.newtomedicaldevicesales.com/pod/ Guide For Breaking into Medical Device Sales Ebook: https://newtomedicaldevicesales.squarespace.com/ New to …
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In this episode of the Global Medical Device Podcast, we’re joined by Elena Kyria, a talent acquisition specialist and CEO of Elemed. Elena delves into what it takes to climb the career ladder in the medtech industry, whether you're early or late in your career journey. Our host, Etienne Nichols, engages in a rich discussion on career paths, levera…
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Ken Riordan, Regulatory Affairs Project Manager at Telos Partners, brings a unique but essential perspective to his clients having worked in both the public and private sector. He was a lead reviewer for the FDA where he conducted scientific and engineering reviews of pre-market applications for cardiovascular devices. Ken’s broad experience in the…
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Regulatory affairs teams have an outsized impact on business revenue, bringing new products to market quickly, managing registrations and licenses to keep products on the market, and staying updated on changing standards and regulations that might impact market clearance. Yet most regulatory affairs teams are treated primarily as operational cost-c…
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The Agilis by Kymanox experts in digital health, Lauren Horn, PhD and Alexandria Kruzer, attended the 2023 AI Summit and share their key takeaways. They showcased a notable shift in AI discussions from continuous learning to the evaluation of large language learning models. Transparency in AI, particularly using SHAP values, emerged as a critical t…
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Going over what it really means when you lose an interview in Medical Device Sales and what it means when you hear that you lost to someone with "more experience" Break into Medical Device Sales Online Course: https://courses.newtomedicaldevicesales.com/pod/ Guide For Breaking into Medical Device Sales Ebook: https://newtomedicaldevicesales.squares…
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In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols engages with Carmen Brown, the regulatory and quality affairs manager at Proxima Clinical Research. They delve into the specifics of In Vitro Diagnostics (IVDs) and explore the challenges and considerations faced by medical device manufacturers in the IVD pathway.…
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