Medical Device 공개
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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 ...
 
TrackMy® Solutions is a web application company centered initially around the healthcare industry using Open API platforms to create better patient facing applications. We focus on the health data elements present in a patient’s electronic health record and pull those into our applications using API Integration. We then make this data easily viewable in our application and allow a patient to track their overall health. TrackMySolutions.us
 
The Medical Sales Podcast is a podcast for people who want to get into medical sales and medical sales reps who want to advance their careers. We interview top medical sales reps and leading sales executives from all over the country in pharmaceuticals, medical devices, genetic testing, diagnostic lab sales and more. You’ll laugh, you’ll learn and you’ll be inspired. If you would like to learn more about my programs visit https://evolveyoursuccess.com
 
This is MedTech True Quality Stories, hosted by Jon Speer, founder and VP of QA/RA at Greenlight Guru. Each week, we embark on a new storytelling journey with different MedTech executives as they share real-world, actionable best practices for medical device leaders. Listeners will gain invaluable insights into how these industry pioneers are successfully imagining, implementing, and improving True Quality medical devices.
 
Every medicine in your pharmacy has a human story behind it. Real people doing real work and living real lives. We all have romantic ideas about scientists working late into the evening or doctors dropping everything to answer a phone call about a patient. You can almost envision the moment when one of those researchers finally solves an intellectual puzzle and leaps into action. Their eyes go from an empty stare to an alert laser-like focus. They sit a bit taller and start to read frantical ...
 
Live Mana Worldwide Foundation is a Non-Profit media company that provides Media, Brand Development, and Event Production services to ministries, non-profits, and purpose-driven individuals. Joshua T. Berglan and his team of experts teach unique strategies, fresh approaches, and effective techniques they learned from some of the most respected and influential minds in business, media, and ministry. Most importantly, you will learn how to get your message to the world, regardless of your budg ...
 
What is the state of information technology now? That’s the focus of each Inertia episode. The question is a broad one as tech intersects across many industries and themes: personal computers, portable devices from the iPhone to GPS systems, microprocessors, applications, social media, search, medical technology, broadcasting and TV, music tech, online commerce, graphics, cloud computing, security, storage, mobility, and enterprise hardware and software... and anything else that references I ...
 
For 50 years, Drug and Therapeutics Bulletin (DTB) has provided rigorous and independent evaluations of, and practical advice on, individual treatments and the overall management of disease for doctors, pharmacists and other healthcare professionals. DTB has always been wholly independent of the pharmaceutical industry, Government and regulatory authorities. DTB is also free of advertising and other forms of commercial sponsorship. Please subscribe to the DTB podcast to get episodes automati ...
 
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show series
 
Why does the FDA have three systems in place to address and handle risk related to medical devices? Each system serves a different purpose, but are all three actually necessary? In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about FDA’s three systems of risk for medical devices and the uni…
 
Mike Eriksen has over 30 years of experience in medical device marketing, and he shares his views on what makes a successful marketing executive. Mike is currently Senior Global Marketing Manager at Smith+Nephew, a leading medical device company. In this episode we discuss issues in marketing and Mike draws from his experiences at RTI Surgical, KCI…
 
Barcode Verifier: Welche Fehler sind finden, welche regulatorischen Anforderungen sie zu erfüllen helfen und was sie kosten. Wenden Sie sich bei weiteren Fragen an Wilfried Weigelt (WWeigelt@rea.de) Prof. Dr. Christian Johner (via Kontaktformular)저자 Wilfried Weigelt, Prof. Dr. Christian Johner
 
Subscribe We talked a lot about the EU MDR and the difficulty for some manufacturers to transition to this new legislation. But today we will explain why IVDR manufacturers will struggle more. I will explain to you the change in terms of product classification within the IVDR 2017/746. Because of this, a lot of manufacturers that didn’t need a Noti…
 
Nursing and medical device sales are both demanding jobs when it comes to scheduling and time management, but in very different ways. Whether you’re willing to change your lifestyle to accommodate the more unpredictable schedule of medical device sales or not is something you might want to consider if you’re thinking about jumping into the role. In…
 
In this episode of the Xtalks Life Science Podcast, Ayesha discusses a report from the Center for Countering Digital Hate (CCDH) and Anti-Vax Watch that shows there are just 12 people behind 65 percent of all online anti-vaccine disinformation. While social media operators such as Facebook and Twitter had vowed to remove vaccine disinformation from…
 
Today's guest is Courtney Richards, the founder and CEO of DMEconnected. Courtney has been a medical representative in the durable medical equipment industry for almost a decade. Seeing the need for a centralized source of information to connect providers to vendors, he created DMEconnected. It's an online marketplace for medical providers to find …
 
How are in vitro diagnostic (IVD) devices similar and different from medical devices? How should IVD manufacturers approach quality management and other key elements based on these similarities and differences? In this episode of the Global Medical Device Podcast, Jon Speer talks to Joanne LeBrun from MDC Associates, which offers quality systems co…
 
Does your medical device qualify for an investigational device exemption (IDE)? What does this process involve and what does FDA expect of these manufacturers? There is plenty to consider when it comes to the IDE timeline and process. In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill “Mr. Regulatory” who sheds v…
 
In this episode of the Xtalks Life Science Podcast, Ayesha discusses the results of a new NIH study that suggest a link between moderate caffeine consumption during pregnancy and lower birth weight and reduced body size. Should pregnant women avoid caffeine altogether, or is this yet another restriction placed on expectant mothers that might not be…
 
Never underestimate the power of having positive psychology in life. It enriches creativity, increases productivity, and delivers the right flow for your skills. But in today's fast-paced world, many people don't even consider putting energy into achieving this state. Samuel Gbadebo sits down with positive psychology expert Jeff Barnard to discuss …
 
Are you a medical device professional or company seeking suppliers? Or, are you a supplier yourself? There’s a supplier management solution that will make your job a whole lot easier. In this episode of the Global Medical Device Podcast, Jon Speer talks to Bassil Akra, CEO and Co-owner of ‎QUNIQUE, a quality and regulatory consultancy. Previously, …
 
Chris Hermann is the CEO of Clean Hands – Safe Hands, a company dedicated to reducing healthcare associated infections through better hand hygiene. In this episode Chris shares what his company is tackling, and the road they have taken from idea, to development, to clinical study to sales. He discusses his take on the customer discovery process and…
 
Premarket Approval (PMA) is a FDA regulatory pathway designated for Class III medical devices that has historically been known to evoke a fearful, negative response by medical device professionals. In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill, known in the industry as Mr. Regulatory, about the reasons why t…
 
Why is design, manufacturing, quality, and culture so important in the medical device industry? These key elements must exist and function in synchrony so that a medical device can save and improve patient lives. In this episode of the Global Medical Device Podcast, Jon Speer talks to Dan Purvis, CEO at Velentium—a design, development, and manufact…
 
This podcast was recorded on March 2, 2021 With a number of COVID-19 vaccines now being authorized for use, how do we decide which is the best? Using data from COVID-19 vaccine trials from Pfizer/BioNTech, Oxford/AstraZeneca, Moderna and J&J, Ayesha explains why vaccine efficacies can't be directly compared — and why vaccine messaging needs to refl…
 
This podcast was recorded on March 15, 2021 In Episode 3 of the Xtalks Life Science Podcast, the team reflects on the 1-year anniversary of the start of the COVID-19 pandemic. Ayesha explains how far we’ve come since March 2020 in terms of vaccine development, but discusses the inequities in distribution of the COVID-19 vaccines despite the establi…
 
This podcast was recorded on February 23rd, 2021 In Episode 1 of the Xtalks Life Science Podcast, Sarah discusses a new condition called “Mask-Associated Dry Eye” and Ayesha talks about Droplet Micron, an innovative insulin needle. Tune into this episode to hear a clip from Sarah’s interview with Dr. Richard Hom, optometric director at Anthem Blue …
 
Ein Serial-Entrepreneur verrät, wie die Startups vorgehen, die erfolgreich sind und kein Geld unnötig verbrennen. Weiterführende Informationen Beitrag zum Sean Ellis Score Buch "The great CEO within" Buch Testing Business Ideas Wenden Sie sich bei weiteren Fragen an Markus Müller: Kontakt via LinkedIn Prof. Dr. Christian Johner (via Kontaktformular…
 
Subscribe This podcast episode is following a presentation I have made during the Greenlight Guru Summit on EU MDR and IVDR. I have explained how to create a label that fulfills the requirements of the EU MDR. I have placed on the show notes the link to it. After the session, I have received a lot of questions and I didn’t have the time to answer a…
 
In this podcast, James Cave (Editor-in-Chief) and David Phizackerley (Deputy Editor) review the April issue of DTB. The editorial discusses variability in the management of people with severe asthma (https://dtb.bmj.com/content/59/4/50). The editors talk about a summary of an article on changes in prescribing of statins (https://dtb.bmj.com/content…
 
Daniel Powell is the CEO of Spark Biomedical, a startup company that developed, and as in the process of launching, a neurostimulation device to provide patients relief during opioid withdrawal. Daniel and his team have developed a solution, based on a proven technology. Daniel discusses Spark and some of the challenges they faced including product…
 
What do manufacturers need to know about the Safer Technologies Program (STeP) for Medical Devices from FDA? How is STeP different from similar programs, like the Breakthrough Devices Program? Which devices are eligible? In this episode of the Global Medical Device Podcast, host Jon Speer and his guest Mike Drues from Vascular Sciences offer answer…
 
One of the main differentiators that makes Greenlight Guru so unique is its Guru Edge. The medical device gurus ⁠are a team of medical device professionals with decades of combined industry experience and subject matter expertise. In this episode of the Global Medical Device Podcast, Jon Speer talks to Sara Adams, a medical device guru at Greenligh…
 
A lot of people in medical device sales started out in the profession with passion, but Clay Steves didn’t have that when he first started out in orthopedic device. Life happened and necessity forced Clay to put in the work, but when he did, the impact that orthopedic had on patients inspired him to persevere. Consumed by the idea of combining phys…
 
In the last of our Emerging Researchers Series, I speak with Shandra Trantham, a Ph.D. candidate at the University of Florida. Shandra was destined for a life in science. As a young child, science and math were her favorite subjects. She and I share the childhood dream of becoming an astronaut. I never followed my dream, but Shandra didn’t even hav…
 
Neue Nahfeldprüfung - Hintergrund und Bedeutung; Schulterschluss mit der FDA und Hilfestellung für das Risikomanagement Wenden Sie sich bei weiteren Fragen an Mario Klessascheck: mario.klessascheck@johner-institut.ch Prof. Dr. Christian Johner (via Kontaktformular) Webseite mit weiteren Informationen auch zu anderen Änderungen: siehe Blogartikel…
 
Subscribe Let’s discuss System and Procedure Pack. We usually talk about medical devices like as an object that is used in the healthcare industry. But when you have to combine multiple objects, how can you then regulate that. Is there one classification for all or should you classify and register each of them. And what if all these objects are alr…
 
In this episode Pat Kothe recaps five critical customer motives that emerged from the first 10 episodes of the podcast and discusses why it is important for people within medical device companies to unravel them. He also discusses some of the issues we will begin to explore in future episodes, broadening out to include interviews with industry peop…
 
What does it take to build a successful MedTech startup? It’s a multi-million dollar question and the answer involves strong execution of a highly strategic plan. In this episode of the Global Medical Device Podcast, Jon Speer talks to Duane Mancini, president and founder of Project Medtech, and host of the Project Medtech Podcast. Listen as Jon an…
 
Most if not all people are trying to get somewhere and go beyond where they are now, whether it’s within their career, company, or industry. If you're someone who wants to take serious steps to make that happen, especially if you’re in the medical sales space, this show is going to be a gem. Today, Samuel Gbadebo talks about Evolve Your Success, th…
 
Subscribe With the EU MDR 2017/745 and IVDR 2017/746 the role of Economic Operators is becoming clearer. In the case you are located outside of Europe and you need to import your Medical Devices in the EU, you need to have an Importer. In this episode we will talk of the importer role and what they need to check before your product is placed on the…
 
What makes Greenlight Guru unique? It’s Guru Edge⁠—a team of medical device professionals with a ton of industry experience. In this episode of the Global Medical Device Podcast, Jon Speer talks to Karen Schuyler, a Medical Device Guru at Greenlight Guru with nearly 15 years of experience working in the medical device industry. Listen as Karen offe…
 
Dr. David Nelson is an anesthesiologist practicing in Austin, TX. With over 30 years of experience in the field, he shares how his practice has changed with outpatient surgery and the emergence of ambulatory surgery centers, what medical devices he uses and why, what documentation really is and why it’s vital for reimbursement, and his message for …
 
Imagine using medical illustrations, animations, and other types of artwork to tell the story of a medical device, its procedures, or its manufacturer. In this episode of the Global Medical Device Podcast, Jon Speer talks to Annie Campbell and Emily Holden from Now Medical Studios, where they create medical illustrations and animations for the heal…
 
What makes a nurse want to shift into medical device sales? Kelly Allan practically got called into the role, but she does have a lot of wisdom to share to nurses who are thinking about making a similar shift. In particular, Kelly believes that nurses already possess essential skillsets that are going to put them in an advantageous position should …
 
Wie Sie mit der korrekten Fallzahlberechnung unnötige Aufwände bei klinischen Studien ebenso vermeiden können wir Ärger bei der Zulassung. Wenden Sie sich bei weiteren Fragen an Dr. Thomas Keller (via E-Mail) Das Johner Institut (via Kontaktformular) Webseite: https://www.johner-institut.de/blog/gesundheitswesen/fallzahlplanung/…
 
Subscribe This month we will review what happened within the Medical Device Industry and there was some updates. Here is the agenda: EUDAMED Covid19 Language for EU MDR 2017/745 MHRA virtual manufacturer update Australia Nanoparticle consultation Singapore Medical device grouping tool Saudi Arabia covid 19 update Easy Medical Expert Green Belt Trai…
 
Software as a Medical Device (SaMD) is a growing sector of the medical device industry. If you are interested in entering the SaMD space, what do you need to know when it comes to FDA regulations and guidance? In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill, “Mr. Regulatory”, who has nearly a decade of firstha…
 
Dr. Paul Davidson is an emergency medicine physician with over 30 years of experience, ranging from Level I trauma centers, to free-standing ER’s, to Urgent Care centers, to small town facilities with very little backup. He explains living through the challenges of the pandemic, what a typical day is like, who he works for and how that’s changed ov…
 
How can medical device companies be better prepared for remote and on-site inspections or audits? Practice, practice, practice so that you’re always audit-ready. In this episode of the Global Medical Device Podcast, Jon Speer talks to Steven Niedelman and Eric Henry, lead consultant and senior advisor for Quality Systems and Compliance, respectivel…
 
Not everyone can successfully pivot from one industry to another. But our guest, Chris Larsen of Next Level Income, was able to do so, and from a totally different niche! Chris transitioned from medical device sales to become a professional investor. Today, he sits down with Samuel Gbadebo to discuss how he built a real estate empire - upholding th…
 
In the latest episode of our Emerging Researchers Series, we talk to Emily McIntosh (@MCINTOSE) a recent Ph.D. from the University of Guelph in Guelph, Ontario. Living less than an hour from Toronto, she is a big Leafs fan (that is the Maple Leafs for all you non-hockey listeners.) Emily earned her doctorate in biomechanics after studying age-relat…
 
In this podcast, James Cave (Editor-in-Chief) and David Phizackerley (Deputy Editor) review the March issue of DTB (https://dtb.bmj.com/content/59/3). The editorial discusses a national safety alert that highlighted the risk of dependence associated with prolonged use of opioids for non-cancer pain and a proposal that all opioid medicines in the UK…
 
Über den Unterschied und die Gemeinsamkeiten von Hilfsmitteln und Medizinprodukten Wenden Sie sich bei weiteren Fragen an Norbert Kamps (TODO: E-Mail bei Lea erfragen)Prof. Dr. Christian Johner (via Kontaktformular)저자 Norbert Kamps, Lea Wettlaufer, Prof. Dr. Christian Johner
 
Subscribe I am really honored to have within this episode of the Podcast Jon Speer. I was already following him before I started Easy Medical Device and now I had the opportunity to interview him. We discussed Medical Device Design, and I wanted his opinion on the best design methodology to use and which trap to not fall in. We discussed particular…
 
The new medical device regulation in the European Union (EU MDR) has introduced a host of new challenges for medical device companies. One challenge, in particular, has to do with the quality management system of a medical device. In this episode of the Global Medical Device Podcast, Jon Speer talks to Monir El Azzouzi, founder and CEO of Easy Medi…
 
Sarah Hermsdorf is a Surgical PA, specializing in neurosurgery, which encompasses surgical intervention in the brain and spine. Sarah discusses the details of her practice from the surgical suite, to hospital rounds, and in the clinic pre and post-surgery. She tells why she values good company representation in the OR, and what the best reps do to …
 
What do auditing and compliance protocols look like during a pandemic? Medical device companies continue to adjust to changing circumstances in an attempt to maintain business as close to normal as possible. In this episode of the Global Medical Device Podcast, Jon Speer talks to Colleen Hittle, founder of ProVeritas Partners, who brings years wort…
 
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