Qmed Consulting - Podcast Details

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In The Den with Mama DragonsTrans Kids, Our KidsSend us a textWe have all been watching the unprecedented attacks on trans healthcare for youth and adults by anti-trans extremists from the local to the federal levels. The trans legislation tracker reports an alarming 857 anti-trans bills under consideration in 2025 alone. Many of us, our kids, and our families find ourselves caught in the eye of this storm. Today In the Den, Sara sits down with special guest Alexis Stratton of The Campaign for Southern Equality to discuss the book that Stratton co-authored called Trans Kids, Our Kids: Stories...2025-05-191h 00

The Qmed PodcastBONUS EPISODE: Structured Dialogue: A Conversation with TÜV SÜDAt Qmed, we believe in fostering open, collaborative conversations to address the challenges faced in the medical device regulatory space. That’s why we’re thrilled to share the recording of our recent webinar with TÜV-SÜD, now available on YouTube and as an audio podcast! 🎙️This discussion began when TÜV-SÜD reached out after seeing one of our LinkedIn posts on structured dialogue with notified bodies. From there, we had the privilege of collaborating on a series of insightful conversations about the challenges and opportunities in improving communication between notified bodies and medical device manufacturers.2025-01-2222 min

The Qmed PodcastBONUS EPISODE: Structured Dialogue: A Conversation with TÜV SÜD 2025-01-2204 min

The Qmed PodcastS5 E8: Academy Talks: Medical Device Documentation: Post Market SurveillanceAs a startup company, post market surveillance can feel far away and not relevant, but key documents are of critical importance to develop during the device development process. The authorities expect companies to have a PMS procedure available and plans for surveillance of PMS and PMCF. We will walk through which active and passive collection methods are available for use to ensure the manufacturer has the data available to fulfil the requirements.2024-12-1308 min

The Qmed PodcastS5 E7: Academy Talks: Medical Device Documentation: Clinical StudiesWe discuss how to define the clinical study endpoints based on your defined safety and performance objectives and the clinical development plan during the clinical validation procedure. We walk through how to design different studies based on available standards and guidelines. Finally we will discuss the importance of the oversight of the clinical investigation and how to do that. We will also touch on the importance of selecting the correct participants and stakeholders to run an efficient and economical clinical investigation.2024-12-0620 min

The Qmed PodcastS5 E6: Academy Talks: Medical Device Documentation: Pre-clinical testing, Verification and ValidationDuring this session, we will walk through how to translate the requirement specifications into a verification and validation plan, including setting up bio compatibility studies, animal studies and bench test and usability tests, etc. We will discuss how to maintain the traceability from the requirements to verification and validation methods. The importance of design freeze during this process is discussed further.2024-11-2917 min

The Qmed PodcastS5 E5: Academy Talks: Medical Device Documentation: Clinical EvaluationWe will walk through the clinical evaluation process starting with the clinical evaluation plan and the literature search as the initial steps to identifying the clinical safety and performance objectives. These two procedures are built on a vigilant search of publicly available databases and establishing a state of the art description of similar and equivalent clinical procedures and devices. The output is the clinical evaluation report. We will additionally walk through who can and when to establish the process of clinical evaluation and how to continuously update the documentation.2024-11-2224 min

The Qmed PodcastS5 E4: Academy Talks: Medical Device Documentation: Risk ManagementThis session will walk you through the overall risk management process. Starting with the description on the risk management plan and how to work with the risk management analysis/HTM matrix. This process is built on several input sources that we will highlight during our discussion and finalise in our risk management report, identifying the final residual risks. The risk management documentation is evaluated during the risk management review process as established in the companies. We will finally highlight how to update the ongoing risk management documentation.2024-11-1520 min

The Qmed PodcastS5 E3: Academy Talks: Medical Device Documentation: Requirement SpecificationsNow that you have your user needs description, we will walk you through how to set the user and device related requirements supported by the list of applicable standards and the device description. Once we have this in place, we will be able to define our clinical claims and clinical and non clinical objectives, Again, we highlight the importance of updating the ongoing documentation throughout the development process.2024-11-0817 min

The Qmed PodcastS5 E2: Academy Talks: Medical Device Documentation: User NeedWe will continue the development of the device description and based on that define our intended user and patient population. We will also discuss what input sources to use and how to create the specific documentation. We will also touch on concept testing that can be used to develop the early stage documents. We will walk you through how to update your user input documents.2024-11-0117 min

The Qmed PodcastS5 E1: Academy Talks: Medical Device Documentation: Stand Alone DocumentsIn our first episode, we will discuss the importance of the device description and the link to the other standalone documents, such as classification, GSPRs, regulatory compliance plan, instructions for use and the list of applicable standards. This will enable you to start out on the right foot with your medical device development project. We hope you find this series helpful! You are so welcome to let us know your thoughts and if you have any questions by commenting below or emailing us at QmedPodcast@gmail.com.2024-10-2526 min

The Qmed PodcastAcademy Talks: Medical Device Documentation 2024-10-2301 min

Global Medical Device Podcast powered by Greenlight Guru#362: Managing Risk in Clinical InvestigationsIn 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 measurable, data-driven approach to balancing risks and benefits and discusses the challenges companies face in aligning their clinical investigations with stringent regulatory standards.Key Timestamps00:00:45 - Introduction to Helene Quie and the topic of risk management in clinical investigations.00:05:22 - Discussing the first leg of...2024-04-2539 min

The Qmed PodcastS4_E2_PMCF survey with CETAS HealthcareDuring this episode we will have CETAS Healthcare share their extensive knowhow and perspective on how to set up PMCF surveys and gather important data fulfilling the MDR requirement.2024-02-081h 03

The Qmed PodcastS04 E01 Biocompatibility with Ted HeiseTed Heise from the MedInstitute is a true subject matter expert within biocompatibility and biological evaluation. He will share during this interesting conversation his view on how to understand the guidances and regulations in the key markets.2024-01-1332 min

The Qmed PodcastS03 E05 - Usual Audit Findings During Medical Device Clinical Studies w. Rikke BoegeI am thrilled to host Rikke Bøge, an esteemed Clinical Affairs Subject Matter Expert, as our special guest on this episode of the Qmed podcast. Rikke's extensive background as a nurse, study coordinator, and Clinical Research Associate brings a depth of experience that's invaluable. She will be sharing her wealth of knowledge and firsthand experiences during audits in the clinical research landscape.Tune in as we explore real-life scenarios, insights, and strategies to navigate the intricacies of audits in clinical settings. Don't miss this opportunity to gain valuable insights from Rikke's expertise!2023-12-0130 min

The Qmed PodcastS03 E04 - Clinical Investigations w. Susanne Dr. Gerbl-RiegerDuring this episode I speak with the subject matter expert Dr. Susanne Gerbl-Reiger about the implementation of MDR and ISO14155 and typical findings observed during her long time experience form AKRA team and TÜV SÜD 2023-11-0350 min

The Qmed PodcastS03 E03 - The Benefit-To-Risk Assessment w. David RutledgeIn this third episode of the Qmed Podcast we discuss the process of identifying, analysing and consluding on the Risk Benefit Assessment. I am interviewing David Rudledge who shares his experience and knowledge working within this field for medical devices the last 25 years. Listen and enjoy!2023-09-2944 min

Safe and EffectiveA Collaborative Approach Between Clinical and HF (ft. Helene Quie)Join us in our fourth episode of Safe and Effective, where we dive deep with Helene Quie, regulatory and clinical expert, and founder and CEO of Qmed Consulting A/S in Copenhagen, Denmark. Together, we explore the pivotal role of a collaborative approach between clinical and human factors teams in order to align with regulatory requirements as well as provide for more robust device safety and performance data. Helene sheds light on the criticality of controlled testing environments and how invaluable insights from real-world scenarios are not just fed back into device design and development to achieve i...2023-09-291h 04

The Qmed PodcastS03 E02 - Digital Health & ReimbursementHave you ever wondered how digital health is driving the future of healthcare?Don't miss our new podcast on "Digital Health And Reimbursement" where Ernesto Nogueira and Helene Quie explore the impact of COVID-19 on digital medical technologies, the different types of digital health, and their applications in healthcare.2023-03-1530 min

Beyond InnovationInnovation in Unexpected Places with Vic Nunes, Founder and CEO, QMed InnovationsIn this episode of Beyond Innovation, I speak with Vic Nunes, Founder and CEO of QMed Innovations about how innovation can take unexpected forms, why deep experience in a category can unlock new ideas and how age can be an advantage when it comes to new ventures. Vic has spent over 30 years in the 2023-02-1533 min

The Qmed PodcastS3 E01 - Sufficient Clinical EvidenceIn the first episode of season 3 of The Qmed Podcast, Helene Quie is joined by Bassil Akra, Akra Team's CEO to discuss the topic of Sufficient Clinical Evidence.Tune in and learn what to consider when gathering clinical evidence, where to look for guidance and much more.2023-01-2543 min

The Qmed PodcastS2 E18 – The Risk-Based Approach in Risk ManagementIn this episode of The Qmed Podcast, Helene Quie is joined by Nadia Ragnvald Caspersen, Qmed Consulting's Quality Manager to discuss The Risk-Based Approach in Risk Management. Tune in and learn why a risk-based approacht is essential for your company, how to identify and address risks within Quality Management.2022-12-2226 min

The Qmed PodcastS2 E17 – Navigating Through CAPAIn this episode of The Qmed Podcast, Helene Quie is joined by Jens Johansen, Qmed Consulting's Manager of Strategic Consulting to discuss the CAPA process. Tune in and learn the advantages of establishing this process, relevant tips on how to conduct it and what the next steps are.2022-11-2218 min

The Qmed PodcastS2 E16 - The Clinical Evaluation PathwayIn this episode of The Qmed Podcast, Helene Quie is joined by Søren Underbjerg, Qmed Consulting's Principal Advisor within Clinical Development, Market Access and Reimbursement to discuss the Clinical Evaluation Pathway. Tune in and find out what stages you should go through, pitfalls, and relevant tips and tricks we have gathered from dealing with notified bodies.2022-10-0449 min

The Qmed PodcastS2 E15 - The IVDR TransitionIn this episode of The Qmed Podcast, Helene Quie is joined by Signe Lundsgaard-Nielsen, Qmed Consulting's Principal Advisor of Clinical Development, Market Access & Reimbursement. Here, we discuss one of this year's hot topics - the IVDR transition. Tune in and find out how your device is classified under the new regulation, what the important timelines are and the main consequences of this change.2022-09-0251 min

The Breakfast GrilleHomegrown Healthcare Tech Solutions For Regional ApplicationsQmed Asia is a homegrown healthcare tech start-up founded in 2018 by doctors who simply hated the long unproductive queues at hospitals. So, they developed an online appointment booking system for healthcare providers and they now have their sights set on going beyond Malaysia's shores. Its co-founder and CEO Dr Kev Lim talks about the journey, the challenges and the dream of Qmed Asia becoming a publicly listed company some time soon.See omnystudio.com/listener for privacy information.2022-09-0223 min

The Qmed PodcastS2 E14 - How to: EUDAMEDThis episode of The Qmed Podcast addresses one of the most talked about topics in the medical device industry nowadays - EUDAMED. Learn more about it with Qmed's expert, Mads Oliver Jensen.2022-08-2517 min

🔸Inside Orthopedics#43 - Anatomy of a startup - Discussion with the Vic Nunes, the CEO and Founder of QMed Innovations (58 mins)Finally, finally, finally... a company has solved the instrument and implant logistics problem. If you are an owner of instrument cases, this is a no-brainer. You should start a Quest pilot next week. You will literally double the effectiveness of these assets. Website - https://qmedinnovations.com/ --- Support this podcast: https://podcasters.spotify.com/pod/show/tigerbuford/support 2022-08-1558 min

The Qmed PodcastS02E13 - Conducting Clinical Studies at HospitalsIn this episode, Helene Quie discusses the topic "Conducting Clinical Studies in Hospitals" with study nurse, Christina Møller.2022-04-2725 min

The Qmed PodcastS02E12 - Submissions in NorwayIn this episode, Helene Quie discusses the topic "Submissions in Norway" with Qmed's Clinical Specialists in Submission Processes. Learn about the country's special requirements, where you can the necessary documentation, and relevant tips and tricks for a successful submission process.2022-03-2513 min

The Qmed PodcastS02E11 - Submissions in DenmarkIn this episode we discuss submissions in Denmark with Clinical Specialist, Christina Duun Nielsen 2022-03-0818 min

The Qmed PodcastS02E10 - Market Access with Søren UnderbjergIn this episode, we are joined by Qmed’s market access expert Søren Underbjerg, to discuss the key elements for developing market access strategies.2021-09-2724 min

Medical Device made Easy PodcastHow to perform a good Clinical Investigation with Helene Quie Clinical Investigation is one of the toughest process within the EU MDR 2017/745. If you have to perform one for your Medical Devices then it can be a long and expensive process. In this episode, Helene Quie from Qmed Consulting, will help us understand how to perform it in a good way. This episode will answer some of the questions you have about Clinical Investigation and we hope this will make more clarity for you. Some of the questions answered are: Which products do need a clinical investigation?Can we test our products on our...2021-06-1500 min

The Qmed PodcastS02E09 - An Update on EudaMed w. Richard HoulihanRichard joined us on a previous episode back in 2019 where he explained basic fundament behind the EUDAMED database. Since then, a lot has happened with the database and in this episode, Richard will provide an overview and explanation of the recent updates and changes to the platform.2021-06-1435 min

The Qmed PodcastS02E08 - How to prepare for the upcoming changes with Norway Health TechIn this episode, we are joined by Kami Faust from Norway Health Tech, to discuss what action all medical device manufacturers should take right now to prepare for the upcoming changes.2021-04-1315 min

The Qmed PodcastS02E07 - With Lasse Staal from AddiFabIn this episode we are joined by Lasse Staal, CEO of Danish 3D-Printing Pioneer, AddiFab, to talk about 3D-printing of medical devices.2021-03-1649 min

The Qmed PodcastS02E06 - With Ernesto Nogueira from ValueConnectedIn this episode of The Qmed Podcast we're joined by Ernesto Nogueira, to talk about Artificial intelligence in the medical device industry.2021-02-2440 min

The Qmed PodcastS02E05 - With Rasmus Lou-Moeller from Meggitt DenmarkThe RoHS directive is coming! Had the pleasure of talking to Rasmus Lou-Moeller, head of R&D at Meggitt Denmark, about the RoHS directive and how it will affect the medical device industry. Through our conversation, Rasmus explained the pros and cons of the directive and gave advice to medical device manufacturers who are currently using piezoceramics in their products.2021-02-1720 min

Medical Device made Easy PodcastHow to find a QA RA job for Medical Devices? [Karandeep Badwal] Subscribe If you find it difficult to get a job in QA RA for Medical Devices, then listen to this episode where Monir El Azzouzi and Karandeep Badwal are giving you some tips on how to integrate this world. They will provide you some tools to use, some podcasts to listen to, some groups to follow. And for sure this will move you few steps forward. If you have any questions, don’t hesitate to ask in the comments. Who is Karandeep Badwal? Mr. Karandeep Singh Badwal is a Regulatory an...2021-02-1600 min

Medical Device made Easy PodcastFebruary 2021 Update – Medical Devices Remote Audit by the EU Subscribe In this monthly episode of the podcast, we do a regulatory intelligence review of what happened monthly. The agenda for this month is: Countdown until EU MDR by Michelle Lott (LeanRAQA)Remote Audit authorized for EU MDR SURVEY Result US update on Recognised Consensus Standards Canada guidance on Vigilance Reporting Training available Notified Body Situation UK Approved Body Guidance and Standards PODCAST and LIVE episodes Look at all the links below. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specialized in Quality...2021-02-0200 min

The Qmed PodcastS02E04 - with Monir El Azzouzi from Easy Medical DeviceClinical evaluation and the equivalence pathway! Are you in doubt if it is still possible to use the equivalence pathway under MDR? Are there different requirement for different classes of products? How to show equivalence under MDR. Hear practical examples based on feedback from the Notified Bodies.2021-01-2752 min

The Qmed PodcastS02E03 - with David Rutledge from Global Strategic SolutionsHad the absolute pleasure of talking to David Rutledge about something I myself find a very difficult assessment process; Benefit - Risk Assessment.The Benefit - Risk Assessment is mentioned 28 times during the MDR and os one of the core processes especially in the clinical evidence process.Through our conversation David made the process very tangible and I would clearly recommend listening to our conversation.2020-05-221h 02

The Qmed PodcastS02E02 - with Victor Staalkjaer and Andreas Tuxen from June SystemsStarting a company within the regulatory field of medical devices contains a long series of restrictions, which at times can seem challenging. In our 2 Episode of our Qmed Consulting Podcast (Season 2), we get an insight of Victor and Andreas, experience within the Quality Management System. The two engineers have developed a Class IIa medical device. The device measures the amount of oxygen within a child under labor. It prevents unnecessary C-sections, and any complications of birth there may occur. The Qmed Podcast gives an understanding of how to navigate in an early start-up phase...2020-05-0828 min

The Qmed PodcastS02E01 - with Bjørn Broby from NeurescueOne of the most common challenges within start-up companies is how to get off the ground and get appropriately funded.Questions regarding budgeting, pick of the investor, deciding the worth of one's company, and many more. We have, therefore, in the first episode, of our new second season, invited Bjørn Broby from @Nerescue to give start-up companies a broader understanding of how to navigate in the funding process. We hope you will enjoy listening in and tap in on Bjørn's vast amount of experience.2020-04-2434 min

Medical Device made Easy PodcastPost-Marketing Clinical Follow-up with Helene Quie (PMCF) PMCF or Post-Marketing Clinical Follow-Up is a cornerstone of the Medical Device Regulation 2017/745. This is why I took the opportunity to ask some questions about it to Helene Quie from Qmed Consulting. I met Helene at Medica 2019 in Dusseldorf and she accepted to help the audience to have a better understanding of PMCF. Helene was part of the podcast episode 40 where we discussed Clinical Evaluation Reports or CER and specifically about the way to prove the equivalence between devices. PMCF is part of this big box that is PMS or Post-Market Surveillance and...2020-01-0600 min

Medical Device made Easy PodcastLiterature Search for your CER with Ed Drower Subscribe As I have performed some Literature Searches and created some CER myself, I know the difficulty and time of doing that. But I also had to audit some CER reports and I am always surprised by the way this is done. With the new Medical Device Regulation EU MDR 2017/745, you will maybe have to update your CERs so this is why I decided to focus on this topic for this episode. To help you perform your CER if they are based on Literature Search, I asked Ed Drower, Director of Regulatory Affairs at...2019-11-1100 min

Medical Device made Easy PodcastProduct Equivalence for Clinical Evaluation Report (CER) with Helene Quie If you are really confused about Product Equivalence for your Clinical Evaluation Report or CER, then you are at the right place. Just hit the play button as Helene Quie from Qmed Consulting will be providing you some great information. On this episode of the Medical Device made Easy Podcast, we will go through some specific aspect of Product Equivalence as: Clinical EquivalenceBiological EquivalenceTechnical Equivalence This master class regarding Clinical Evaluation Report (CER) will help you be compliant for the new Medical Device Regulation EU MDR 2017/745. The mindset of Notified Bodies changes so they will...2019-09-0800 min

The Qmed PodcastThe Qmed Podcast #10 with Helene QuieIn this final episode of our first season, Helene looks back at great interviews we've had and share some of her favourite conversations and takeaways. This is a great episode for those who are new to the podcast, but also for our avid listeners to make sure they haven't miss the important points from our talented guests. Have a great summer - See you in the fall!2019-06-211h 26

The Qmed PodcastThe Qmed Podcast #9 with Heidi M. MehrzadHuman factors and usability are terms often used interchangeably. Yes, it can be a tricky topic, and one that can create some confusion. Therefore, in this episode, I've invited Heidi Mehrzad from HFUX Research to guide us on the difficult topic. Hope you will enjoy listening in and tap in on Heidi’s vast amount of experience.2019-06-141h 29

The Qmed PodcastThe Qmed Podcast #8 with Richard HoulihanIn this episode of The Qmed Podcast we'll be joined by Richard Houlihan, to talk about "The EUDAMED database and the basic fundament behind". Being part of the European Commission MDR Eudamed technical management position Richard can provide a unique prospective on Eudamed’s inner workings and design bring a better understanding of the Eudamed technical challenges facing companies.2019-06-0728 min

The Qmed PodcastThe Qmed Podcast #7 with Charlotte PiesterIn this episode we are joined by Charlotte Piester from Sinua Partners and discuss how to use clinical and regulatory requirements as commercial competitive advantages within the MedTech industry, completely aligned with the changes to the MDR and the need for companies to carefully consider their claims, market access and which data to collect when – creating The Evidence Gap Plan.2019-05-3121 min

The Qmed PodcastThe Qmed Podcast #6 with Ernesto NogueiraIn this episode of The Qmed Podcast we're joined by Ernesto Nogueira, to talk about key steps for SMEs to know about, regarding commercialisation when starting up the development of their innovative new medical device. Ernesto has numerous years of experience within this field assessing and applying the value of medical technologies in commercial and market access projects. He is sharing with us key questions to ask yourself early stage during the development process to ensure that you can successfully launch your idea when ready.2019-05-2431 min

The Qmed PodcastThe Qmed Podcast #5 with Dr. Bassil AkraIn this episode we're proud to welcome Dr. Bassil Akra. We are discussing the MDR - the new regulation and changes to come seen from the side of the Notified Body and touch on important topics such as Technical Documents, new reports such as SPUR and SSCP and use of clinical evidence from equivalent products for low risk class products.2019-05-1048 min

The Qmed PodcastThe Qmed Podcast #4 with Sandra FerrettiIn this episode we’re joined by Sandra Ferretti from the Obelis Group and Authorised Representative out of Brussels and we are discussing the EUDAMED database and the role of the Authorised Representative under the MDR.2019-05-0342 min

The Qmed PodcastThe Qmed Podcast #3 with Gert Andersen 2019-04-2649 min

The Qmed PodcastThe Qmed Podcast #2 with Semih OktayIn this episode we're guested by Semih Oktay, President and founder of CardioMed Device Consultants. We touch upon getting an overview of FDA structure and organisation and changes to come by June 2019, Risk classification, FDA approval processes and more.2019-04-191h 14

The Qmed PodcastThe Qmed Podcast #1 with Hilde VirouxIn the first episode of The Qmed Podcast we’re joined by Hilde Viroux from HCL Technologies, to talk about MDR conversion strategy, including maximum use of ‘grace period’, product prioritization, product rationalization and more.2019-04-091h 10

Advanced Manufacturing NowUBM Discusses Trends, Technology, Challenges in Medical Device IndustryAmanda Pedersen, News Editor of MD+DI (Medical Device and Diagnostic Industry) and Qmed, discusses the trends and technology in the medical industry, such as artificial intelligence, surgical robots and virtual reality, and the opportunities and challenges associated with them. She also talks about UBM's presence at three co-located events in Boston on April 18-19: the Embedded Systems Conference, BIOMEDevice Boston and Design & Manufacturing New England.2018-04-0527 min

Questioning Medicine18. Holy Grail of Diabetes DiscussionThe Dr James McCormack from BS Medicine joins QMed and helps us enlighten listeners about some of the great and terrible evidence in DM. Revelations regarding symptom management and risks surrounding this disease spectrum. Lift your spirits and recharge your Evidence Based Medicine soul! COMMENT! EMAIL! TWEET!2014-11-2759 min