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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.
 
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 ...
 
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 ...
 
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 ...
 
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.
 
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
 
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, ...
 
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 ...
 
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, ...
 
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show series
 
When the Unique Device Identification (UDI) system was first announced by FDA several years ago, the accompanying draft guidance left much ambiguity and confusion among manufacturers who struggled to understand what it was, why it mattered, and what to even do with it. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Dr…
 
Die Geheimwaffe für eine kürzere Time 2 Market oder ein regulatorisches Minenfeld? Wenden Sie sich bei weiteren Fragen an Matthias van der Staay Prof. Dr. Christian Johner (via Kontaktformular) Webseite: https://www.johner-institut.de/blog/iec-62304-medizinische-software/code-generierung/Matthias van der Staay, Prof. Dr. Christian Johner tarafından oluşturuldu
 
We are at 9 months of the EU IVDR 2017/746 date of application. So let’s t talk of the Transition period for such products. We have done that also for MDR 2017/745 when the date was nearly due. So today we’ll tell you about: Differences between IVDD 98/79/EC and IVDR The Hard Transition Period – The Soft Transition Period The UDI transition period …
 
Device Nation sits down with author, motivational speaker, blogger, podcaster and Sports Medicine Orthopedic Surgeon, Dr. Vonda Wright! We talk about building a brand and building people, an inspiring conversation!!! Womens Health Conversations: https://womenshealthconversations.com Clinic Site: https://www.northside.com/medical-professionals/gradu…
 
3Eye joins Krishna Vishnubhotla from Zimperium for another episode of Beyond the Device to discuss some of the biggest mobile security stories of 2021 and how Zimperium works to address security breaches. Hosted by: Reid Estreicher, VP of Business Development, 3Eye Technologies https://www.linkedin.com/in/thereid/ Guests: Krishna Vishnubhotla, VP o…
 
Barbara Strain is an expert in Value Analysis and Management. Barbara has forty-one years of provider experience, thirty-four of them in the University of Virginia Health System where she led teams in Value Management and Supply Chain Analytics. Barbara is one of the founders of the Association of Healthcare Value Analysis Professionals (AHVAP), an…
 
This is the audio-only version of RQM+ Live! #39, originally recorded 26 August, 2021. The climb to MDR certification is well underway for device manufacturers. It's been quite an undertaking, but with careful planning, budgeting and execution, it has and will lead to continued successful commercialization of medical devices and IVD’s in the EU. Ho…
 
In this episode of our tech podcast, Vikram Gulati, Country Head & Sr V. P at Toyota Kirloskar Motor, joins host Nandagopal Rajan to discuss the future of electric vehicles in the Indian market. From the automobile market's shift towards electrification to the issue of charging, the duo discuss all you need to know about electric vehicles in India.…
 
Edward Lifesciences’ acquisition of Percutaneous Valve Technologies helped mark the birth of one of medtech’s great game-changers – the development of the transcatheter aortic valve replacement.In this week’s episode, Stanton Rowe, the former CEO of PVT, will walk us through the early days of TAVR, including the enormous doubt the start-up faced as…
 
There are many schools of thought when it comes to the 'who, what, and when' of quality management for medical devices. In this episode of the Global Medical Device Podcast Jon Speer talks to Christie Johnson with Kasota Engineering, a consulting firm focused on quality in the medical device industry. Listen to this episode as Jon and Christie offe…
 
First of all, I am not encouraging anyone to sue anyone. This is only educative content to know what is possible and what is the best strategy to do it. We will talk about the reason one company would sue its Notified Body and also about the good method and the bad method to do it. Some of the discussions are based on real-life experience. Anyway, …
 
In the latest episode of our tech podcast, Rick Bergman, the Executive Vice President of Computing and Graphics at AMD, joins host Nandagopal Rajan to discuss how the pandemic is shaping the computing industry. The topics they cover range from gaming and high performance computing and graphics to the competition in the processor market, the demand …
 
What makes Greenlight Guru unique and sets it apart from other medical device solutions? 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 Maryann Mitchell, a Medical Device Guru and Solutions Engineer who has recently joined the Greenlig…
 
Kinamed has high-quality, door-opener products that are truly unique. We talk about the amazing Supercable, Patient-specific PFJ and Carbojet....Check them out! Kinamed: https://www.kinamed.com Roy Fiebiger Vice President, Global Sales rfiebiger@kinamed.com What's in YOUR bag? Support the show (https://www.venmo.com/DeviceNation)…
 
This month we will cover a lot of specific rules that are applied in some countries: USA UK France Finland Switzerland And then we’ll look at Events planned, Notified Bodies, MDCG guidances released, and the Podcast episodes. Enjoy! Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. A…
 
Device Nation sits down with an Orthopod trapped in a Diagnostic Radiologist's body, Dr. Joseph McGinley! We talk about McGinley Innovations, his office-based practice, patents, what is was like to swim Alcatraz, and more!!! McGinley Innovations: https://www.mcginleyinnovations.com Clinic Site: https://wyomingmedicalcenter.org/doctor/joseph-mcginle…
 
In the latest episode of our tech podcast, Ankit Gupta, Head of Engineering at Cult.fit joins host Nandagopal Rajan to discuss the technology behind customised digital fitness. From how fitness apps are personalised for users to whether digital fitness can replace actual gyms, the duo discuss a host of related issues.…
 
This week, DeviceTalks Weekly Podcast examines the single-use endoscope market.We’ll hear from market leaders Ambu and Boston Scientific in a replay of interviews we conducted in September 2020. Guests include Ambu’s CEO Juan Jose Gonzalez and Stephen Block as well Boston Scientific’s Endoscopy executives Dr. Brian Dunkin, chief medical officer, an…
 
You’ve got a great idea for a medical device! Now what? Most errors in clinical trials are a result of poor planning. Fancy statistical methods cannot rescue design flaws. Thus careful planning with clear foresight is absolutely crucial for clinical trial success. With the explosion of Medtech opportunities for startups, what are the current best s…
 
Medical device companies need to tell slightly different versions of their stories depending on the intended audience—investors, suppliers, regulators, clinicians, and patients—and each version must be strategically crafted and told in order to convey the right message. In this episode of the Global Medical Device Podcast Jon Speer talks to Brad Pe…
 
Dr. Nishi Viswanathan is the Director of Texas Health Catalyst, a program inside Dell Medical School at The University of Texas at Austin that provides researchers, innovators and entrepreneurs customized guidance on product development from industry and clinical experts as well as milestone-based seed funding. In this episode Nishi shares the prob…
 
Software as a Medical Device is really a difficult topic. First, because it is quite new in the EU Regulation, and second because we cannot make a generality and should consider each software one by one. In this episode, we asked directly a Notified Body to tell us exactly how we should view this field and what are the tips or warnings. So I have i…
 
In this episode of Indian Express’ tech podcast, Anand Singh, Head of Developer Relations and Localisation at India OS, joins host Nandagopal Rajan to discuss the evolution of smart phone users in India and how Indus OS has been helping bridge the language chasm in India. The conversation ranges from the challenges faced by Indian app developers to…
 
New therapeutic approaches require fresh perspectives, and few perspectives were as fresh as Dr. Steven Mickelsen, the developer of a potentially paradigm shifting cardiac ablation treatment – pulse field ablation.Dr. Mickelsen, a high school dropout turned musician, fell deep enough in love with electrophysiology to go back to school, obtain a med…
 
Cheryl Nagowski is an expert in Federal Market Access. She runs a consulting firm, Middleton Market Access, and her team helps companies with their federal market strategy and helps them obtain access to the federal markets. In this episode Cheryl shares the size of the federal markets, how they’re organized, the steps to successful access and impl…
 
Is your body becoming more frail? Are you worried about fractures? Do you want to improve your bone health? Osteopenia and osteoporosis are very common problems that don’t have completely effective solutions, yet. In this episode of the Global Medical Device Podcast, Jon Speer talks to Laura Yecies, CEO of Bone Health Technologies, about the produc…
 
Device Nation sits down with a surgeon you need to know, Dr. Brett Sanders! We talk about his life, his practice, guitar, RC repair and do some transosseous tunneling!! Tensor Surgical: http://tensorsurgical.com/2020/ Adaptable Shoulder Positioned: https://www.djoglobal.com/products/djo-surgical/adaptable-shoulder Banjo Tab: https://www.ultimate-ta…
 
Let’s describe to you the life of a Healthcare industry consultant with Smahan Toughrai. Within this episode, we will ask the question like: Why would we choose a consultant job? Should people have a certain skill to be a good consultant? Is the salary a good motivation to be a consultant? Is it better to work for a small company or a multinational…
 
In this episode of Indian Express' technology podcast, host Nandagopal Rajan is joined by Gargi Dasgupta, Director of IBM Research in India, to discuss how the pandemic has accelerated the adoption of Artificial Intelligence (AI). From how AI helped businesses reach out to customers and how it is changing the nature of jobs to the humans vs AI deba…
 
Let's get interventional. This week, we talk with leaders from Abbott and Cordis about their plans to advance of medtech's stablest business. Duke Rohlen, executive chair, will explain to co-host Tom Salemi why he led the purchase of Cordis from Cardinal. Meanwhile, Dr. Nick West, CMO and DVP of vascular at Abbott, updates Associated Editor Sean Wh…
 
3Eye joins Kern Smith from Zimperium to discuss Chrome Extension security concerns and the impact of these vulnerabilities on the education space. Hosted by: Reid Estreicher, VP of Business Development, 3Eye Technologies https://www.linkedin.com/in/thereid/​ Guests: Kern Smith, VP - Pre-Sales America's, Zimperium https://www.linkedin.com/in/kernsmi…
 
FDA published a final rule, which goes into effect the first of September, to amend its “intended use” regulations. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the implications of FDA’s final rule on intended use, manufacturer’s objective intent, and the role that it has with labe…
 
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After few months of MDR, I proposed TÜV SÜD share with us the most common mistakes they find during their audits. And Martin Witte accepted to summarize some of them. So in this episode, you will hear the TOP 3 issues that are discovered so you can be prepared for it. You will see that some of them are obvious and others are more subtle. Administra…
 
Afdah interface has no ads or irritating popups while streaming online movies. You can watch movies from anywhere or on any device. Afdah Offers you plenty of movies that you can enjoy with your family. No need to go to cinemas when Afdah gives you a cinematic experience at home. https://anchor.fm/afdah-2/episodes/Afdah-Watch-Movies-Online-with-hig…
 
In this episode of our tech podcast, Nishant Sardana who looks after Wireless and Home Entertainment at Amazon India joined host Nandagopal Rajan to talk about the e-commerce giant's growth trajectory in the country, especially after the pandemic began. The duo discuss insights from Prime Day sale, how Amazon is growing its customer base in tier II…
 
This week’s episode focuses on the entrepreneurs. We open up with an interview with Andy Doraiswamy, founder and CEO of Koya Medical, a company he founded to help find a therapy for his ailing father. Then we revisit with Dr. Todd Brinton, chief scientific officer and corporate vice president at Edwards. This interview initially ran in May 2020 but…
 
John Dayton is an Emergency Medicine Physician who has practiced in settings as diverse as the University of Utah Hospital and the Navajo Nation Reservation. In this episode John shares what it’s like to practice medicine on a reservation, how he built his company, Medforums, which is a Yelp for medical education, what he has learned as an angel in…
 
On the agenda for this month Episode we will talk about the latest news and here are few topics that I will present to you: Team-NB Position Paper Harmonized Standards Free ISO standards MHRA guidance on Software as Medical Devices Training EU MDR Green Belt in August Notified Bodies situation MDCG guidances Easy Medical Device Podcast episodes Don…
 
Device Nation sits down with a surgeon you need to know, Dr. Selene Parekh! Co-Chief Foot and Ankle Division, Director of Digital Strategy and Innovation at Duke University, a great conversation about another exploding sub-specialty. We talk about his life, his practice, Lasso socks, Fantasy Doctors and Indian food among others!! The Fantasy Doctor…
 
In this episode of our tech podcast, Saket Modi, an ethical hacker, and co-founder and CEO of Safe Security joins host Nandagopal Rajan to discuss navigating the online world after the Pegasus spyware scandal. the discussion ranges from how Pegasus works and safety on Android vs iOs to what users can do to secure themselves. Time codes: 01:47 How P…
 
This week's episode focuses on new hope for people with diabetes. Brad Paddock, CEO of CeQur, explains how its "wearable pen" can deliver insulin in a better way while Sean Salmon, head of Medtronic's diabetes business, reviews that company's growing portfolio. He also gives insights on its intriguing partnership with the private equity group, Blac…
 
Have you ever thought about the versatility of an eQMS? As it turns out, the use of one medical device eQMS solution in particular is extending across multiple sectors. In this episode of the Global Medical Device Podcast, Jon Speer talks to Renee Rogge and Devin Hubbard, two academic professors/faculty members of biomedical engineering programs wh…
 
John Keane is the Co-Founder and CEO of MindRhythm where they are developing an interesting technology to help diagnose stroke early, when treatment decisions can have a big impact on patient outcomes. In this episode, John discusses why emerging technology is his true calling, what types of people are drawn to it and how he identifies them for his…
 
Within this Masterclass, I will explain to you how to implement a vigilance reporting system with all the links for all the documents we talk about. Vigilance reporting is a system that you need to have in place for your Quality Management System even if you are still MDD compliant. If you get a serious incident or a Field Safety Corrective Action …
 
The bioelectronics industry is poised to take off so we visited with Carolina Aguilar, CEO/Co-founder, INBRAIN Neuroelectronics about the field's potential. Chris Newmarker, executive editor of life sciences at MassDevice, delivers his Newmarker's Newsmakers highlighting news from Dexcom, NeuroMetrix, Nevro, Ancora and the Galien foundation.Subscri…
 
This is the audio-only version of RQM+ Live! #38, originally recorded 22 July, 2021. Market consolidation and acquisitions along with the relocation of design centers and manufacturing facilities to OUS locations are resulting in what appears to be a continuous cycle of site transfers for medical device companies. RQM+ is a strategic partner to the…
 
Soft launches are an important tool when introducing any new product to the market. In this episode Pat discusses why you do a soft launch, what you are trying to learn, some key issues related to the types of customers who buy in the early phases, and setting expectations. He shares why Key Performance Indicators are important to establish up fron…
 
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