Medical Device عمومی
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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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The Podcast That Will Dive Into The Exciting and Ever Changing World Of Medical Device Sales. Join Founder And Host, Gyda Loveres, Who Has Been In The Space For Over 13 Years, And Listen As She Explores The Ins And Outs Of This Fascinating Industry. Gyda Together With Her Guest, Will Uncover The Secrets, Challenges, And Triumphs That Come With Selling Medical Devices. You Will Hear First-Hand Stories From Industry Professionals, Gain Insights From Experts, And Navigate This Ever-Evolving Wor ...
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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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Listen To Ben's Interviewing Journey:https://youtu.be/C29PzqdS7Pg?si=tdnkGfLGOzQI_TcG Website:https://www.newtomedicaldevicesales.comBreak into Medical Device Sales Online Course:https://courses.newtomedicaldevicesales.comGuide for Breaking into Medical Device Sales Ebook:https://www.newtomedicaldevicesales.com/product/guide-for-breaking-into-medic…
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In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Dr. Matthew Wettergreen, Director of the Global Medical Innovation Master of Bioengineering program at Rice University. Dr. Wettergreen shares his extensive experience in developing client-based engineering design courses and discusses the importance of global and …
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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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In Today's Episode, We Will Explore The Strategies And Mindset That Drive Success In The World Of Sales. We Will Be Diving Into A Topic That Is Crucial For Every Sales Professional: The Importance Of Self-Confidence In Sales. Sales Can Be A Challenging And Competitive Field, Where Rejection And Setbacks Are A Part Of The Game. In Order To Thrive In…
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Send us a Text Message. In this episode, the discussion centers around the crucial role of advisory boards in guiding company strategies, product development, and business initiatives within the medical device sector. Featuring insights from Paul Hickey, CEO of ReShape Life Sciences, the conversation delves into best practices for forming and manag…
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Woran Software-Projekte oft kranken Michael Nauditt, Geschäftsführer der Moguru GmbH, unterstützt mit seinem Team Unternehmen bei der Software-Entwicklung, auch das Johner Institut. Im Interview mit Prof. Johner berichtet Michael Nauditt von typischen Problemen, auf die er und sein Team stoßen, wenn sie in Projekte gerufen werden. Er schildert die …
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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, host Etienne Nichols is joined by Mark DuVal, President and CEO of DuVal & Associates, and Kathy Herzog, Senior Regulatory, Quality, and Compliance Associate at DuVal & Associates. They delve into the recent FDA proposed rule for wound dressings, addressing the classification and regulatory impacts on medical device manufacturers. …
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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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Welcome To Episode 10 Of The Device Diaries Where We Talk Everything MedDevice!! In Today's Episode Titled How Doing The Hard Stuff In Life Can Make You Better In Sales, We Will Explore The Connection Between The " Hard Stuff" And Becoming A Competent Sales Professional. My Guest Today Is David Holte, A Seasoned Sales Professional & President's Clu…
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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 sits down with Dr. Gail Lebovic, an internationally recognized oncoplastic surgeon and innovative entrepreneur. They delve into the evolving landscape of MedTech, focusing on the shift from traditional reimbursement models to direct-to-consumer strategies. Dr. Lebovic shares her …
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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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In Today's Episode, We Will Explore Strategies And Insights To Boost Sales Performance. Our Topic Today Is Very Exciting As We Delve Into Communication In Sales. Joining Me Today Is A Seasoned Sales Professional With A Track Record Of Success, Lori Jolley. We Hope You Find The Discussion On Communication In Sales Enlightening And Informative. Remem…
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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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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, We Are Diving Deep Into The Fascinating World Of Persuasion Techniques. Whether You Are A Sales Person, Marketer, Or Simply Interested In Improving Your Communication Skills, This Episode Is For You. So Grab A Pen And A Paper, And Let's Get Started!! Support the Show. Device Diaries Founder/Host: Gyda Loveres.…
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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, Etienne Nichols is joined by Shaherah Yancy, CEO of Research Lifecycle Solutions. They dive deep into the critical importance of developing robust clinical and regulatory strategies for MedTech companies. Shaherah shares her extensive experience in the field, providing practical advice on securing funding, ensuring market access, a…
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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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Rejection Is Something That We All Encounter At Some Point In Our Lives. Whether It's A Job Application, A Romantic Relationship, Or A Creative Project, Rejection Can Leave Us Feeling Discouraged And Uncertain About Our Abilities. But What If I told You That Rejection Can Actually Be A Catalyst For Growth And Self- Improvement? In Today's Episode, …
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Tucker Sahnow: https://www.linkedin.com/in/tuckersahnow/ 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 Ye…
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Usability-Studien international, gesetzeskonform und effizient durchführen Der Usability-Experte Dr. Philipp Schleer berichtet aus der Alltagspraxis darüber, weshalb Usability-Studien notwendig sind, in welchen Fällen diese in verschiedenen Ländern (parallel) geführt werden sollten, welche typischen Herausforderungen dabei entstehen und wie man die…
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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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In Today's Competitive Landscape, Digital Marketing Has Become An Essential Tool For Driving Sales And Achieving Success. In This Podcast, We Explore Why Digital Marketing Is A Must In Sales And How It Can Significantly Impact Your Business Growth. Join Me And My Very Special Guest/ Mentor, Omar As We Delve Into The Various Aspects Of Digital Marke…
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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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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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In Today's Episode, We Will Explore The Intersection Of Emotional Intelligence And Success In Selling. Selling Is More Than Just A Product Or Service, It's about Building Relationships, Understanding Customer Needs, And Connecting On An Emotional Level. E.Q. aka Emotional Intelligence, Plays A Crucial Role In Achieving Success In Sales. Join Me And…
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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, along with part-time co-host Stephanie Hinton, dives into the art of clinical trial recruitment with Dr. Kelly Palmer, Assistant Professor at the University of Arizona. Dr. Palmer shares her extensive experience and innovative strategies for overcoming recruitment challenge…
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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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In this episode of the Global Medical Device Podcast, host Etienne Nichols talks with Mitch Robbins, founder of the Anthony Michael Group, about the evolving landscape of hiring and job seeking in the MedTech industry in 2024. They discuss strategies for both employers and job seekers, emphasizing the importance of preparation, effective communicat…
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In Today's Episode Titled " The Power Of Pivoting", We Will Explore The Power Of Personal And Professional Growth. Join Me And My Guest Dhillon Alamshaw, A Seasoned Trauma Rep As We Embrace New Pivoting Strategies When The Old Ones Don't Work. Support the Show. Device Diaries Founder/Host: Gyda Loveres.…
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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 is joined by Jamie Bihary, a Medical Device Guru at Greenlight Guru. Jamie shares her journey from biomedical engineering to her current role, where she helps companies transition from legacy quality management systems (QMS) to cutting-edge electronic QMS (EQMS). They discus…
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In this episode of the Global Medical Device Podcast, host Etienne Nichols chats with Weronika Michaluk and Zach Markin from HTD Health about their journey to achieving ISO 13485 certification. The discussion covers the importance of gap analysis, the value of a compliant agile approach, and the benefits of using Greenlight Guru’s eQMS software. Li…
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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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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 engaging episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Ron Richard, a seasoned expert in the medical device industry with over 35 years of experience. The discussion delves into the essentials of bringing a medical device to market, from the inception of an idea to commercialization. Ron shares his journe…
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In this episode of the Global Medical Device Podcast, host Etienne Nichols welcomes back Dr. Mike Drues to discuss the critical aspects of obtaining Institutional Review Board (IRB) approval and interacting with the FDA for medical device clinical trials. They explore the roles of IRBs, the difference between significant and non-significant risk de…
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