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RQM+ industry-leading experts discuss timely regulatory and quality topics medical device, IVD, and combination product companies are facing. RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed ex ...
 
Join us on DeviceAlliance's Podcast: MedTech Radio where we interview today's brightest minds in Southern California's medical device industry. Each episode deconstructs complex topics and provides the tactics, tools, and strategies to overcome tomorrow's challenges. DeviceAlliance strives to be the one-stop-shop at the center of the medical device ecosystem helping drive collaboration, innovation, and career development for all device professionals in Southern California.
 
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 ...
 
LiveTile est un podcast sur l'actualité du monde Windows et Windows en mobilité, notamment grâce à Windows 10 et aux "Surface". Nous recevons régulièrement des invités appartenant à cet univers. A chaque épisode, nous effectuons une revue de presse de l'actualité écoulée, des tests d'applications et des freetiles (la minute non Windows Phone). Généralement, nous diffusons un nouvel épisode chaque 15 jours.
 
Hosted by Anexinet Sr. Mobile Strategists Steven Brykman and Glenn Gruber, this podcast covers all aspects of Digital Transformation, including strategy, mobility, security, development, design, testing and more. Anexinet is a leading technology consultancy and reseller, focused on technology-enabled business transformation strategies and solutions. Anexinet (www.anexinet.com) customers benefit from our holistic approach—from engaging front-end interactions to dependable back-end solutions, ...
 
We're taking a deeper dive into the culture we live in. We'll need three things: (1) An understanding of the culture we find ourselves in. (2) A sharp analysis of the cracks in the smooth, seemingly solid narrative that our culture tells us about what it means to live a good life. (3) A new imagination of what it looks like for the gospel of Christ to open up and thrive from within the cracks of our culture. This podcast comes from clergy and laypeople at Church of the Atonement in Buffalo, ...
 
Device is a monthly book discussion with a science-based twist. In each episode, we discuss a novel that uses science to drive the story’s action, and dissect the plot device for scientific plausibility.
 
The Beyond Devices podcast is brought to you by Jan Dawson and Aaron Miller. Jan is the author of the Beyond Devices blog, as well as the owner and Chief Analyst at Jackdaw Research, a research and advisory firm focused on the consumer electronics market. Aaron is a business school professor, but in a past life ran one of the most popular iMovie blogs and co-authored several books in the iMovie: the Missing Manual series with David Pogue, and remains an avid follower of all things Apple. Jan ...
 
How can new technology help you to play a new musical instrument? The E-Sense research programme is experimenting with novel augmentation devices to explore sensory, bodily and cognitive extension. In this interdisciplinary research, philosophy and art combine with various flavours of computing: ubiquitous; wearable; and physical. We take a look at how E-Sense's speculative philosophical research experiments, built on the 1960's work of Paul Bach-Y-Rita's minimal tactile vision sensory subst ...
 
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
 
No matter how tech savvy you are, your kids likely have you beat. Digital natives see the world in a fundamentally different way than all previous generations. This makes 21st century parenting an unprecedented challenge. Join Marc Groman, an Obama White House tech and privacy adviser, and David Reitman, an adolescent medical doctor, for candid discussions and helpful tips about screen time, social media, sexting, privacy, online gaming, and other challenges facing parents today. Marc and Da ...
 
Download a full audiobook of your choice free at http://audiobookspace.com/free Let Us Tell You a Story. We've got more than 100,000+ incredible audiobooks that will take you anywhere you want to go. We have it all! Bestsellers, classics, award-winners, romance, thrillers, Fiction, business, bios, young adult and more. What do you want to listen to? Take your books anywhere with our free apps for iOS and Android. Listening on-the-go has never been faster, easier or more enjoyable. We've intr ...
 
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show series
 
Are you on the frontlines of developing new medical devices and technologies during COVID-19? Or, are you a customer who has benefited from using them? In this episode of the Global Medical Device Podcast, Jon Speer talks to Alison Lee about her PPE startup Breathe99, which pivoted operations in developing its high-quality face mask product to meet…
 
Wie die VDE-AR-E 2842-61 nicht nur Herstellern von KI-Systemen hilft, "Trustworthiness" zu erreichen Wenden Sie sich bei weiteren Fragen an Dr. Rasmus Adler Dr. Henrik Putzer Prof. Dr. Christian Johner (via Kontaktformular) Webseite mit weiteren Informationen: https://www.johner-institut.de/blog/systems-engineering/ki-systeme/…
 
Bob Beck is one of the pioneers in national accounts and has helped shape how industry manages our most important customers. In this episode Bob describes what a national account is, how to work with group purchasing organizations, integrated health delivery networks and other strategic accounts. He also shares how to best work internally with the …
 
Kickoff of the Brown Bag Series! Flow FX has a great suite of clinically unique products to deliver biologics (PRP, BMAC, DBM, ABX, Calcium Phosphate/Sulfate) to the operative site. A lot of fun to show as they are non-threatening and bring value. Check it out! Flow Fx: https://flow-fx.net/products/ Ryan Wright E-mail: r.wright@flow-fx.net What's i…
 
This is the audio-only version of RQM+ Live! #32, originally recorded April 8, 2021. The MDR Date of Application is just around the corner, and there is no indication of another delay coming. If some or all of your products won't be ready in time, you may be starting to panic. In this show we'll start by debunking the bad ideas that we've heard. He…
 
3Eye joins Holly Davis from Komplément and Jason Claybrook from Aura Wireless to discuss a variety of funding programs available to schools and how the CARES Act and E-Rate are impacting the world of education. Hosted by: Reid Estreicher, VP of Business Development, 3Eye Technologies https://www.linkedin.com/in/thereid/​ Guests: Holly Davis, CEO, K…
 
In today's Modern Digital Enterprise, the digital transformation podcast from Anexinet, Steve and Glenn discuss NFTs with Andy Ofiesh, former Software Engineer for Bitcoin Armory. Are they a speculative investment or a status symbol? Proof of ownership or proof of fandom? What are the risks? What are the benefits? Non-Fungible Tokens (NFT)s are cry…
 
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…
 
This week, Liane Teplitsky, vice president and general manager of worldwide robotics at Zimmer Biomet, shares her excitement for the burgeoning data business emerging in orthopedics. Teplitsky, an engineer who built her medtech career in the cardiac R&D and sales at St. Jude and Abbott, walks us through the interconnected offerings of Zimmer’s ZB e…
 
Before In the city, Empty lots are Monuments To scarcity. The soil is cracked And scarred, Overgrown with weeds Who offer some kind Of green, But only takes away. Now In the city, Gentle hands trained in Gospel abundance Of the country Are healing the soil, Kissing its scars, Breaking it open In new ways for, Greener, Generative kinds.…
 
Do you fear needles and the associated pain? No one understands this fear more than physicians who see it firsthand with their patients day in and day out. And one physician in particular set out to do something about it. In this episode of the Global Medical Device Podcast, Jon Speer talks to Dr. Amy Baxter, CEO and founder at Pain Care Labs. Amy …
 
In this episode, host Nandgopal Rajan is joined by Jean Jacques Blanc, the Chief Commercial Officer of iRobots. Beginning with the company's latest offerings, the duo discuss how cleaning robots are evolving to offer a personalised experience to each consumer, how the idea of home cleaning has evolved, smart home integration, and a lot more.…
 
In this week’s podcast, Derek Herrera explains how a serious battle injury he received while leading Marines in Afghanistan led him to build a career in medtech. Herrera has founded two companies – Spinal Singularity and Habit Camera – to create devices that can improve and save the lives of people who need help the most. Herrera also explains how …
 
Après trois semaines de pause non-voulue, nous reprenons le chemin des micros à trois, Cassim, Flobo et Guillaume, pour vous parler ce soir de matériel. Bien sûr, nous faisons un tour de l’actualité et passons voir les nouveautés d’Edge, les surprises des dernières builds et finissons classiquement chez Xbox pour parler de jeux vidéo ! Pour nous fa…
 
Device Nation sits down with the top volume joint surgeon in the US, Dr. Robert E. Booth! Over 47,500 joint replacements and counting, he is a co-designer of five TKA systems over a 20-year period, and is an internationally known speaker and educator. An amazing life story, you don't want to miss this inspiring conversation with one of the giants! …
 
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…
 
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…
 
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…
 
Founded in 2010, Xiaomi, a global Chinese company, swiftly rose to become one of the world’s top smartphone brands. In India, its largest market, the company has successfully managed to tap into the consumer’s value consciousness. In this episode, host Nandagopal Rajan is joined by Jayadevan P.K, a technology journalist and author of Xiaomi: How a …
 
This week, we’ll talk with Lisa Earnhardt, executive vice president, medical devices at Abbott about how the life sciences giant pivoted during the pandemic. Earnhardt shares what programs were given greater priority when the impact of the lockdown became clear and why the company performed so well in one of its key businesses.We also explore this …
 
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…
 
We are going for a "Therapy-Free" listening experience today with Orthopedic Surgeon Dr. Andrew Wickline! We talk about growing up in West Virginia, Swiftpath, racing cars and why he is the top volume surgeon in NY with the lowest complications. Clinic Site: https://www.andrewwicklinemd.com Swiftpath: https://swiftpath.andrewwicklinemd.com We concl…
 
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, …
 
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)על ידי Wilfried Weigelt, Prof. Dr. Christian Johner
 
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…
 
While coronavirus hit the global live sporting events industry hard initially, it did not take too long for sports federations and broadcasters to begin experimenting with technology to cut losses. In this episode, host Nandgopal Rajan is joined by Dhaval Ponda who leads media and entertainment globally at Tata Communications. The duo discuss how t…
 
Hologic CEO Steve MacMillan says last March he didn’t appreciate how COVID-19 would change the world forever. But the diagnostics company quickly rose to the challenge, creating one of the surer supplies of diagnostic tools to chart the pandemic's severity.In this DeviceTalks Weekly Podcast, MacMillan shares how Hologic pivoted to meet the calls fo…
 
This is the audio-only version of RQM+ Live! #31, originally recorded March 25, 2021. In connection with biological equivalence, the MDR states, “the device uses the same materials or substances in contact with the same human tissues or body fluids for a similar kind and duration of contact and similar release characteristics of substances, includi…
 
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…
 
Fr. Bryan ministers in a more progressive culture, within the city of Buffalo. Fr. Andrew ministers in a more conservative culture in Texas. How can we learn together how the gospel transcends these cultural forces and speaks the transformation of Jesus to all places? The Reverends interview each other about the various challenges they face in reac…
 
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…
 
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…
 
3Eye joins Amico for a conversation on how COVID-19 has changed the healthcare industry and how Amico products solve problems for physicians adjusting to a focus on telehealth. Hosted by: Reid Estreicher, VP of Business Development, 3Eye Technologies https://www.linkedin.com/in/thereid/​ Guests: Jim Owens, District Sales Manager, Amico https://www.…
 
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…
 
Launched in early 2020, Koo drew people's attention when it won the government’s Atmanirbhar App Innovation Challenge. The microblogging site was co-founded by entrepreneurs Aprameya Radhakrishna and Mayank Bidwatka. Most recently, it saw its user base shoot up while the government and Twitter were involved in a tussle. In this episode, Nandgopal R…
 
HAPPY BIG 5-0!!This week’s is our 50th DeviceTalks Weekly Podcast, and we’re going to celebrate! Ashley McEvoy, Executive Vice President, Worldwide Chairman, Medical Devices, Johnson & Johnson, makes her DeviceTalks Weekly debut.In this update, McEvoy delivers great insights on several areas of interest including:• COVID-19’s impact on J&J in the p…
 
Pour cet épisode 203, vous retrouver un classique trio d’animateurs : Cassim, Florian et Guillaume. Pour changer, nous vous proposons une première partie assez importante qui traite de l’univers Xbox et du GamePass grâce aux annonces liées à l’arrivée de Bethesda dans le giron de Microsoft. Après cela, nous faisons un point sur les sorties, les ann…
 
Finally, a Medical Device Podcast restoring the listener to their pre-arthritic alignment....Yes, we are talking with Orthopedic Surgeon and Kinematic Alignment Evangelist, Dr. Stephen Howell! We talk about his life in the military, ACL reconstructions, how to become a better surgeon, and of course, his seminal developmental work in Kinematic Align…
 
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…
 
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…
 
COVID-19 has put the MedTech industry at center stage with unparalleled demand for diagnostic tests, personal protective equipment (PPE), ventilators, and other critical medical supplies. In addition to the extraordinary measures underway to rapidly ramp up manufacturing capacity and capabilities, MedTtech companies are also looking outside their n…
 
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…
 
Cyber security is proving to be a major challenge with remote working becoming a reality ever since the pandemic began. Vulnerability to cyber attacks increased since home workers no longer had access to firewalls and blacklisted IP addresses that office networks provided. In this episode, Nandgopal Rajan speaks to Paul Ducklin, a senior technologi…
 
Shacey Petrovic, CEO and president of Insulet, explains how the company is giving people with diabetes new tools to manage their disease, a never-ending task that can require HUNDREDS of decisions per day.In this interview, Petrovic explains why research wasn't for her; why she decided to leave her first CEO job to join Insulet; and how the company…
 
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זכויות יוצרים 2021 | מפת אתר | מדיניות פרטיות | תנאי השירות
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