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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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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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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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 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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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 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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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 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 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 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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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 special episode of the Global Medical Device Podcast, Etienne Nichols switches roles from host to guest as Devon Campbell turns the tables to explore the invaluable lessons Etienne has learned from over 100 podcast episodes. Delve into key insights on product development, quality management, and the power of vulnerability and networking. Et…
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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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In This Special Episode, I Will Be Joined By A Guest In The Name Of Courtney Turich, She Is Linked-In Top Sales Voice, Global VP Of Sales, And Marketing, Dynamic Leader, Change Agent And Strengths Champion. In 2014's Season 5, Episode 22 Of The Popular TV Show Shark Tank, She Landed A Deal And Ended Up Partnering With Mark Cuban and Lori Greiner An…
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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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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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In The Fast-Paced And Ever-Evolving Field Of Medical Device Sales, Preparation Is Key. It's What sets apart The Top Performers From The Rest. Today, We'll Uncover The Strategies, Techniques, And Mindset Required To Excel In This Competitive Industry Through Effective Preparation. Join Your Host Gyda Loveres And Her Guest Jarett Mitchell, A Pharmace…
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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 engages with Howard Root, former CEO of Vascular Solutions and author of "Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Fed’s Hit List," and Mark Duval, President and CEO of DuVal & Associates. The episode delves into the harrowing experiences of navigating sever…
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Send us a Text Message. Joe Steele is Head of Commercialization at Hemosonics, where they are providing point-of-care solutions to help clinicians make more informed decisions on blood product usage. In this episode Joe shares why moving up the ladder too fast may not be the best way to go, why experiencing failure will help in the long-run, how to…
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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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In This Very First Episode, Join Gyda and Her Special Guest Jeff As They Uncover The Secrets, Challenges, And Triumphs That Come With Selling Medical Devices. You Will Hear Firsthand Stories From Industry Professionals, Gain Insights From Experts, And Navigate Through The Unique Landscape Of This Dynamic Field. Throughout This Podcast, I Will Featu…
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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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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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In this episode, Lisa Van Ryn, a seasoned expert from Greenlight Guru, shares her extensive knowledge on the FDA’s Medical Device Reporting (MDR). We unpack the nuances of when and how to report incidents, the definition of serious injuries, and the importance of effective complaint management systems. Lisa provides practical advice on setting up r…
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In this episode, host Etienne Nichols speaks with Christine Luk, Associate Regulatory Affairs Manager at Proxima, about her journey through the medical device sector. From her academic beginnings in biochemistry and biomedical engineering to founding a startup and navigating FDA regulatory pathways, Christine offers a wealth of knowledge. The discu…
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Send us a Text Message. Stuart Simpson is CEO of Think Surgical. During his stellar 24-year career at Stryker he led an orthopedic industry transformation that established surgical robotic joint replacement as a standard of care, beginning with the acquisition of Mako Surgical in 2013. In this episode he shares his roots in medical device and how o…
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Ein wirklich nachhaltiges Projekt benötigt Ihre Spende alter Computer Bereits seit über zehn Jahren hilft der Verein HITA e.V. (Healtchare IT for Africa) Pflegekräften und Hebammen im Ghana bei der Weiterbildung, indem er Lernarbeitsplätze mit PCs ausstattet und am Laufen hält. Dabei spielt die Nachhaltigkeit eine große Rolle: Ausschließlich alte P…
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May 4th Scottsdale Arizona Meetup: https://www.newtomedicaldevicesales.com/event 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-medic…
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In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols delves into the journey of Dr. Lee Hunter, an orthopedic surgeon and innovator in elbow surgery devices. Dr. Hunter shares his experience from the conception of a simple yet effective surgical device through its development, struggles with initial licensing, and u…
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In this episode of the Global Medical Device Podcast, host Etienne Nichols engages with Helene Quie, an expert in medical device regulations and clinical investigations. They delve into the dual aspects of risk management: ensuring product safety and the procedural risks associated with clinical protocols. Helene emphasizes the importance of a meas…
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