Medical Device ציבורי
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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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Grounded in GRIT, our mission is to be ambassadors for professional women in the medical device sales industry, helping them tap into their potential, magnify their mindset & escalate their careers by providing real world every day scenarios, struggles and solutions.
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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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Schnell zu präzisen, kompakten und normkonformen Risikomanagementakten Die Definitionen von Begriffen wie Gefährdung, Gefährdungssituation und Schaden erscheinen ebenso kurz wie klar. In der Praxis zeigt sich aber, wie schwierig es ist, "Probleme" mit Medizinprodukten und deren Ursachen korrekt den Konzepten zuzuordnen. Doch wenn dieses Fundament n…
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What if the secret to selling isn’t about your product but the energy you bring into every conversation? In this empowering episode, The Girls of Grit sits with the author of The Spirit of Selling, Rhonda Petit. Rhonda shares her journey from sales professional to peak performance coach, emphasizing the transformative power of mindset and universal…
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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? Claire Dyson is a seasoned professional in the Med Tech space having spent more than a decade in manufacturing and the last 5 years in certification bodies. She beg…
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Picture This, 20-plus Years Ago, A Time When Social Media Was Still A Futuristic Concept. Being A Sales Rep In Those Days Meant Hitting The Streets Armed With A Briefcase Full Of Product Samples And A Pocket Full Of Business Cards. It Was A World Where Face-To-Face interactions And Building Genuine Relationships Were The Keys To Success. In Today's…
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In this episode, Etienne Nichols talks with Leo Eisner, renowned as the "IEC 60601 Guy" and founder of Eisner Safety Consultants, about the importance of selecting the right standards in medical device development. Leo shares his journey into the world of medical device standards, offering a detailed look into the role that standards play in ensuri…
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Was Unternehmen bei unternehmensweiten Datenmodellen beachten sollten Die Bedeutung der digitalen Transformation für die eigene Wettbewerbsfähigkeit verstehen immer mehr Unternehmen. Aber der Glaube, dass ein unternehmensweites Datenmodell eine Voraussetzung für eine erfolgreiche Transformation ist, erweist sich oft als falsch. Im Gegenteil: Für di…
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What if the price objection you keep hearing isn’t really about the cost? In this episode, the Girls of Grit dive deep into one of the most common challenges in sales—cost objections. With years of experience, they reveal an important insight: it’s rarely about the price tag but rather the perceived value. Whether you’re selling a $50 product or a …
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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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In This Episode, We Will Dive Into A Crucial Yet Overlooked Aspect Of Sales- Building Relationships With Gatekeepers. Understanding How To Connect With Them Can Make A Significant Difference In Your Sales Strategy. Hope You Enjoy This episode. Please Remember To Follow, Like, And Hit Subscribe. Support the show Device Diaries Founder/Host: Gyda Lov…
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In this episode, Etienne Nichols interviews Perry Parendo, an expert in Design of Experiments (DOE), about the practical application of DOE in medical device development. They discuss how DOE can be used to better understand systems, reduce risk, and solve complex problems, especially in R&D and manufacturing processes. Perry shares insights from h…
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Eine Lageeinschätzung eines Senior Vice Presidents Regulatory Affairs Stefan Fischer ist Senior Vice President Regulatory Affairs bei der Paul Hartmann AG. Er verrät den Hörerinnen und Hörern dieser Podcast-Episode, welche Erwartungen an Führungskräfte im Bereich Regulatory Affairs gestellt werden, welche Herausforderungen er dabei bewältigen muss,…
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How can we avoid being a "one-hit wonder" in medical device sales? In this episode, The Girls of Grit delves into the crucial strategy of maintaining excellence and avoiding complacency. They explore the discomfort of realizing you're no longer the expert in the room and offer practical advice on how to consistently elevate your game. Cindy and Lis…
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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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Getting Back From A 3 Day Weekend Can Be Daunting. Just The Thought Of Catching Up On Emails As Well As Customer Demands Can Seem Like A Never Ending Task. But Fear NOT... In This Episodes, We Will Talk About Strategies That I Personally Apply To Help Me Stay On Track, Post Holiday. Support the show Device Diaries Founder/Host: Gyda Loveres.…
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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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In this episode of the Global Medical Device Podcast, host Etienne Nichols speaks with Dr. Asha Parekh, CEO and co-founder of Frontline Medical Technologies, about her path from a biomedical engineer to an "accidental entrepreneur." Dr. Parekh shares how her desire to create impactful medical devices led to the development of the COBRA-OS, a life-s…
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How can you rebuild your passion and excitement after career setbacks? In this episode, The Girls of Grit reveals their top secret for overcoming challenges and rebuilding success. They dive deep into how to recover from a decline in performance, a territory realignment, or other career obstacles by tapping into the power of the "honeymoon phase." …
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Today, We Are Diving Into A Topic That Can Redefine How We Think About Sales: Thinking Outside The Box." Sales Is Often Seen As A Straightforward Process- Identify A Need, Present A Solution, Close The Deal. But What Happens When We Encounter Obstacles Or Stiff Competition? That's Where Thinking Outside The Box Comes To Play. Today, We'll Discuss U…
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In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Subhi Saadeh, host of the Combinate Podcast and an expert in the field of combination products. They explore the complexities of combination products—those that integrate drugs, devices, and biologics—highlighting the regulatory challenges and industry growth. Subh…
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How can you deliver a gold medal performance in medical device sales? In this episode, The Girls of Grit draws inspiration from the Olympics to reveal the secret to achieving gold medal performance in the medical device industry. They highlight the parallels between Olympic athletes and top-performing sales professionals, emphasizing the importance…
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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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Networking Is Not Just About Attending Events And Collecting Business Cards, It's About Building Genuine Relationships That Can Drive Sales Success. In Today's Episode, We Will Talk About The Impact Networking Can Have On Sales Success. We Will Start By Understanding Why Networking Is So Important In Sales. Building Relationships Through Networking…
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Send us a text In this episode, we dive into the essentials of branding with expert Howie Chan, founder of Healthy Brand Consulting. The discussion covers the critical role of understanding and managing one's brand, both for companies and individuals. Howie shares insights from his journey from biomedical engineering to branding, offers practical a…
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How is AI transforming medical device sales? In this episode of Secrets in Medical Device Sales, The Girls of Grit chat with Jim Mercadante, Senior Vice President of Growth and Revenue, about AI’s growing role in healthcare. Jim shares his journey from medical devices to AI, driven by his passion for technology and its potential to revolutionize pa…
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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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In this episode of the Global Medical Device Podcast, host Etienne Nichols speaks with Vernon Baker, a medical device guru, about key strategies for early-stage MedTech companies, particularly around implementing Quality Management Systems (QMS), supplier management, and compliance. Vernon shares his experience of transitioning from engineering to …
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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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Why talk less in the OR? In this episode, The Girls of Grit dive into the crucial topic of effective communication in the operating room. They reveal the "Morse code of the OR" and discuss why sometimes less is more. Over-talking can disrupt teamwork and patient care, so understanding when to speak and when to listen is key. They provide practical …
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In Today's Episode, We Are Going To Explore The Power Of Staying Calm In This Fast Paced And Often Stressful World Of Sales. Get Ready To Uncover How Maintaining A Calm Demeanor Can Lead To Better Outcomes And Increased Success. 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, Etienne Nichols hosts Laura Maher to discuss the critical role of design assurance in medical device development. They explore the importance of ownership in design and development documentation, delve into the complexities of design controls, and share practical insights on how to ensure compli…
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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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In this episode, The Girls of Grit continues their conversation with Alisha Merlo. With 25 years of experience in the medical aesthetic industry, Alisha shares her unconventional path, from retail and telecommunications to her true calling in healthcare, showcasing the power of resilience and seizing opportunities. Alisha reflects on her transition…
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How can a passion project become a life-changing force for good? In this episode of The Girls of Grit, we’re joined by Alisha Rose Merlo, a veteran in the medical aesthetic industry with over 20 years of experience. Alisha shares her journey of transforming her dedication to ending human trafficking into a powerful mission. Driven by personal chall…
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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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