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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 ...
 
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 ...
 
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
 
This interactive podcast is hosted by Eric Anderson, President Extremity Surgical, interviewing guests that include medical device executives, Orthopedic surgeons, hospital administrators and staff, and others who experience disruptive technology in the Orthopedic space. Hard hitting interviews with the correct amount of information, humor, and surprise twists.
 
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
 
The Over a Drink podcast is on a mission to normalize the idea of men talking about normal things such as mental health, shame, and pain. After years of sitting in the shame of an eating disorder, I was prompted with the question of "Do you think that you’re the only one who deals with shame? The only man in the world hurting?" As a former SEC football player, I have spent hundreds of hours in locker rooms around tough guys. Spending time as a medical device sales rep, I spent a lot of time ...
 
The Oliver Wyman Health Podcast features conversations with leaders who are pioneering the transformation of the health market. Oliver Wyman’s Health & Life Sciences Practice is a leader in value-based, consumer-centric healthcare, and serves clients in the pharmaceutical, biotechnology, medical devices, provider, and payer sectors. Topics covered in this series include the business challenges of transforming healthcare from volume to value, consumer engagement, consumer experience, digital ...
 
Gregory Laurence, MD introduces cell surgery and explains the purpose of this podcast series addressing the role of the use of stem cell and stromal vascular fraction. Regenerative medicine, in its broadest definition, includes: Nutrition, risk avoidance, exercise, bioidentical hormone replacement therapy (BHRT), platelet rich plasma (PRP), and cell surgery (the topic of this series). There is much confusion regarding the cellular area of regenerative medicine. It has not been fully determin ...
 
SMASH stands for "Serious Medical Advisors Saving Healthcare" and "IT" stands for Information Technology. Through this podcast we intend to invite guests who provide powerful feedback that will impact listeners and help to inspire a revolution in healthcare of those who are like-minded, educated, and technology driven, to engage collectively in the transformation of healthcare as we know it. We will engage in tantalizing topics that surround what it means to think differently when it comes t ...
 
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show series
 
When he was 25 years old, Jacob McLaughlin moved from being an athletic trainer to a surgical sales representative for one of the top medical device companies in the world. He used some traditional techniques for breaking in, but also some that were very non-traditional, including documenting his journey in his podcast, New to Medical Device Sales …
 
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/על ידי Matthias van der Staay, Prof. Dr. Christian Johner
 
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 …
 
In this edition of Device Week, Medtech Insight’s Marion Webb gives a summary of this year’s American Academy Of Orthopedics annual meeting, where she discusses new products from a range of companies, and interesting meetings with executives. UK-based reporter Barnaby Pickering sheds light on Owlstone Medical’s new diagnostic method, and Editor Ree…
 
In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Fazila Seker, president and CEO of MOLLI Surgical. She explains the benefits of the MOLLI Surgical system as compared to the way breast tumors are traditionally located and marked for surgical removal. F…
 
There are individual moments in every person's life that whether you like it or not will shape everything from that time forward. For Tyler Roberts, the loss of his father at a young age was one of those moments. His roles as husband, father, and worship leader are all influenced by the fact that he was thrust into the position of "man of the house…
 
In this episode, we hear from Julia Marquardt, Corporate Accounts Executive with Boston Scientific. Julia imparts the wisdom gained from hiring dozens of medical sales representatives and interviewing hundreds of candidates as a senior leader in the medical device industry. You'll hear the top 5 attributes hiring managers look for in candidates, an…
 
Pink Sheet reporters and editors discuss new developments in US drug pricing reform, FDA considering mandatory opioid prescriber education again, and including China in the agency’s international parallel review initiative, Project Orbis.על ידי Informa
 
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…
 
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the three systems of risk as they relate to the U.S. regulatory system. While many are familiar with the device classification system, they may not be as familiar with the other two systems or their purpose. Whether or not all thre…
 
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…
 
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, …
 
Jordan Hunt has spent a good portion of his life exploring his Faith. Raised in a Christian home he was taught about Jesus from the beginning but as he got older and life got harder the questions in his faith got louder until he began to question God completely. At a low point in his life defined by drugs, alcohol, and mental illness, he joined a c…
 
Pink Sheet reporters and editors consider the leadership shake-up at the FDA Office of Vaccines Research and Review, the COVID-19 vaccine booster shot debate, and the impact of new safety measures for several JAK inhibitors.על ידי Informa
 
15 episodes deep and Bob and Jonny B Lightning dive into all facets of "Pricing Transparency" in Medical Device and healthcare. How does it affect of the overall cost of healthcare? Will transparency help to eliminate waste and drive efficiencies in healthcare to the forefront? The Hospital Price Transparency rule went into effect on January 1, 202…
 
Davinderpreet Mangat, David Dahan, and Ellie Davenport discuss new developments in the diffuse large B-cell lymphoma (DLBCL) and melanoma space. Topics covered include:• DLBCL – CAR-T therapies: 1:23• DLBCL – Polivy: 12:40• Melanoma – Lifileucel: 20:20• Melanoma – Keytruda: 27:25Supporting links:https://service.datamonitorhealthcare.com/hkc/disease…
 
In this week’s podcast, Marion Webb discusses the future of robotic surgery and Barnaby Pickering breaks down the trauma fixation device market.The archive of Device Week and the rest of Informa Pharma Intelligence’s podcasts are available on the Informa Pharma Intelligence channel on Apple Podcasts, Google Podcasts, SoundCloud, TuneIn, Spotify Pod…
 
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…
 
On this episode of the Orthoidea podcast we have the honor of speaking with Jantzen Cole who is the VP of Marketing with Artelon. Artelon's unique technology made of a dynamic biomaterial restores stability and natural motion, resists necrosis, and regenerates natural tissue through load sharing for tendons and ligaments. Revolutionary to say the l…
 
In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Russ Johannesson, CEO of Glooko. He speaks about the advantages remote monitoring offers to both physicians of diabetics as well as the patients themselves. He also offers insights into how his solution is u…
 
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 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…
 
Kevin Balzer is a husband and dog dad. He is a data analyst who volunteers to lead worship at his church. All of that is what he considers normal, and so is the fact that he wakes up every morning without some of his most loved people in his life. Kevin's testimony was self-described as "normal" or "uneventful" until he walked into a storm that was…
 
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 both the US and EU, we are seeing a push for large-scale cosmetics regulation, with the Personal Care Products Safety Act and European Green Deal respectively. For HBW Insight executive editor Ryan Nelson, this raises questions about what and whom it will serve ultimately, particularly when compared with the burdens being levied on industry and …
 
On this week’s podcast we discuss the US agency’s final regulation on the intended use of products, which device makers must follow beginning on 1 September.Medtech Insight articles addressing topics discussed in this episode:• FDA Widens Scope In Considering Evidence For Off-Label Useעל ידי Informa
 
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…
 
On this episode of the Orthoidea podcast we have the distinct pleasure of speaking with Laura Eyman, M.B.A. who is a Supply Chain expert and consultant currently. She comes from a clinical background as a nurse for several years, and then took on several roles in hospital management in the supply chain department. She has conducted several Value An…
 
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…
 
In this month’s podcast, Medtech Insight's Reed Miller and Marion Webb provide a recap of our digital health coverage in July, including start-ups that grabbed new funding, product launches and regulatory clearances. Listen to the podcast via the player below:Medtech Insight articles addressing topics discussed in this episode:Exec Chat: New CEO of…
 
In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Steven LeBoeuf, founder of Valencell. He provides insights on his company’s biomedical sensors, which can be incorporated into many different types of technologies, from fitness clothing to bracelets to …
 
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…
 
To the untrained eye, Kory Miller is simply a 20 something-year-old guy who is an influential social figure. A worship leader for Red Rocks Worship living the dream with his songs on the radio and music platforms accumulating streams in the range of 30 million. But what you see under the light and in front of the camera all too often is far from re…
 
On this episode of the Orthoidea podcast we have the honor of speaking with Vadim Gurevich who is the CEO of Novastep. Novastep has brought revolutionary products to the Foot and Ankle space, and has several new projects in the works. GLW which is a company that Vadim is also a part of is collaborating with distribution partners across the country …
 
Pink Sheet reporter explains the increased pressure on the FDA now that a coronavirus vaccine booster plan is in place, the surprising results of a survey of agency advisory committee members, and the recalculation of FY 2022 PDUFA fees.על ידי Informa
 
In this week’s podcast, Medtech Insight's US Commercial manager Reed Miller provides an overview of Abbott’s Amplatzer Amulet, which was approved by the US FDA for preventing thrombus embolization in patients with nonvalvular atrial fibrillation. Managing editor Marion Webb discusses Zimmer Biomet’s FDA clearance of its Rosa robotic surgery platfor…
 
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…
 
In episode 14 we journey through the technological realm that most of us experience daily in different shapes and sizes. We "sometimes" efficiently interact socially and operate in our own private lives and circles, with the use of technology, better than one may do at a top tier organization. Team SMASH focuses on medical device suppliers and thei…
 
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…
 
As the entry deadline (1 September) for the UK OTC Marketing Awards approaches, HBW Insight Senior Editor David Ridley talks to multi-award-winning agency Satellite PR's Pauline Kent about how to put together a winning entry.על ידי Informa
 
Aaron Smith is a husband, father, and Green Beret Medic with 7 tours under his belt. In his life today, he wrestles the PTSD from the time spent overseas and the mental battles that come side by side with that. In this episode, Aaron shares stories of his time in the military, how he got there, how the Lord walked him through it, and how He is lead…
 
In this week’s podcast, we take a look at the concerns a US FDA advisory panel recently expressed about Keystone Heart’s TriGUARD 3, then discuss some expert predictions on the FDA’s hotly anticipated Quality System Regulations (QSR) rewrite.על ידי Informa
 
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זכויות יוצרים 2021 | מפת אתר | מדיניות פרטיות | תנאי השירות
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