https://www.qmed-consulting.com/
This podcast is for you, if you’re facing challenges within all stages of getting a product to market. To help you we’ve gathered some of the greatest and most influential minds in the Medical Device industry, to get their insights on how to go from an idea to a market success.

You'll be accompanied by our host, Helene Quie, the founder and CEO of Qmed Consulting.]]>enHealth & FitnessCopyright Qmed Consultinghttps://d3wo5wojvuv7l.cloudfront.net/t_rss_itunes_square_1400/images.spreaker.com/original/b53b21b4579d3a74f78e22e479857522.jpghttps://www.qmed-consulting.com/Wed, 22 Jan 2025 10:50:08 +0000Qmed ConsultingQmed Consultingqmedpodcast@gmail.comReady to move into the MDR space? This podcast is for you, if you’re facing challenges within all stages of getting a product to market. To help you we’ve gathered some of the greatest and most influential minds in the Medical Device industry, to get...
This podcast is for you, if you’re facing challenges within all stages of getting a product to market. To help you we’ve gathered some of the greatest and most influential minds in the Medical Device industry, to get their insights on how to go from an idea to a market success.

You'll be accompanied by our host, Helene Quie, the founder and CEO of Qmed Consulting.]]>cleanepisodichttps://www.spreaker.com/episode/bonus-episode-structured-dialogue-a-conversation-with-tuv-sud--63803686
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.]]>https://api.spreaker.com/episode/63803686Wed, 22 Jan 2025 10:36:30 +0000Qmed ConsultingAt 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...
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.]]>1345clean1fullhttps://www.spreaker.com/episode/s5-e8-academy-talks-medical-device-documentation-post-market-surveillance--63298319https://api.spreaker.com/episode/63298319Fri, 13 Dec 2024 10:00:11 +0000Qmed ConsultingAs 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...534clean5fullhttps://www.spreaker.com/episode/s5-e7-academy-talks-medical-device-documentation-clinical-studies--63178077
]]>https://api.spreaker.com/episode/63178077Fri, 06 Dec 2024 09:00:07 +0000Qmed ConsultingWe 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...
]]>1223clean5fullhttps://www.spreaker.com/episode/s5-e6-academy-talks-medical-device-documentation-pre-clinical-testing-verification-and-validation--63058656https://api.spreaker.com/episode/63058656Fri, 29 Nov 2024 11:30:20 +0000Qmed ConsultingDuring 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...1038clean56fullhttps://www.spreaker.com/episode/s5-e5-academy-talks-medical-device-documentation-clinical-evaluation--62965440https://api.spreaker.com/episode/62965440Fri, 22 Nov 2024 11:21:34 +0000Qmed ConsultingWe 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...1495cleanfullhttps://www.spreaker.com/episode/s5-e4-academy-talks-medical-device-documentation-risk-management--62751431https://api.spreaker.com/episode/62751431Fri, 15 Nov 2024 11:17:57 +0000Qmed ConsultingThis 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...1254clean54fullhttps://www.spreaker.com/episode/s5-e3-academy-talks-medical-device-documentation-requirement-specifications--62657963https://api.spreaker.com/episode/62657963Fri, 08 Nov 2024 09:00:02 +0000Qmed ConsultingNow 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...1020health,medicaldevice,requirementspecificationclean5fullhttps://www.spreaker.com/episode/s5-e2-academy-talks-medical-device-documentation-user-need--62579804https://api.spreaker.com/episode/62579804Fri, 01 Nov 2024 11:00:02 +0000Qmed ConsultingWe 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...1031health,medicaldevice,userneedclean52fullhttps://www.spreaker.com/episode/s5-e1-academy-talks-medical-device-documentation-stand-alone-documents--62494208We 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.
]]>https://api.spreaker.com/episode/62494208Fri, 25 Oct 2024 08:00:02 +0000Qmed ConsultingIn 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...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.
]]>1617documents,health,medicaldeviceclean51fullhttps://www.spreaker.com/episode/academy-talks-medical-device-documentation--62472690https://api.spreaker.com/episode/62472690Wed, 23 Oct 2024 11:09:30 +0000Qmed Consulting86cleanfullhttps://www.spreaker.com/episode/s4-e2-pmcf-survey-with-cetas-healthcare--58613331https://api.spreaker.com/episode/58613331Thu, 08 Feb 2024 18:47:35 +0000Qmed ConsultingDuring 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.3812clean42fullhttps://www.spreaker.com/episode/s04-e01-biocompatibility-with-ted-heise--58240338https://api.spreaker.com/episode/58240338Sat, 13 Jan 2024 10:48:52 +0000Qmed ConsultingTed 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.1964clean41fullhttps://www.spreaker.com/episode/s03-e05-usual-audit-findings-during-medical-device-clinical-studies-w-rikke-boege--56995466Tune 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!]]>https://api.spreaker.com/episode/56995466Fri, 01 Dec 2023 05:00:02 +0000Qmed ConsultingI 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...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!]]>1842clean35fullhttps://www.spreaker.com/episode/s03-e04-clinical-investigations-w-susanne-dr-gerbl-rieger--56995442https://api.spreaker.com/episode/56995442Fri, 03 Nov 2023 09:01:04 +0000Qmed ConsultingDuring 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 SÜD3053clean34fullhttps://www.spreaker.com/episode/s03-e03-the-benefit-to-risk-assessment-w-david-rutledge--56995229https://api.spreaker.com/episode/56995229Fri, 29 Sep 2023 17:18:28 +0000Qmed ConsultingIn 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...2653clean33fullhttps://www.spreaker.com/episode/s03-e02-digital-health-reimbursement--53208327Don'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.]]>https://api.spreaker.com/episode/53208327Wed, 15 Mar 2023 08:18:59 +0000Qmed ConsultingHave 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...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.]]>1851cleanfullhttps://www.spreaker.com/episode/s3-e01-sufficient-clinical-evidence--52538213Tune in and learn what to consider when gathering clinical evidence, where to look for guidance and much more.]]>https://api.spreaker.com/episode/52538213Wed, 25 Jan 2023 10:40:43 +0000Qmed ConsultingIn 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...Tune in and learn what to consider when gathering clinical evidence, where to look for guidance and much more.]]>2634clinicalevidence,medicaldeviceclean31fullhttps://www.spreaker.com/episode/s2-e18-the-risk-based-approach-in-risk-management--52255516https://api.spreaker.com/episode/52255516Thu, 22 Dec 2022 10:20:29 +0000Qmed ConsultingIn 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...1582clean218fullhttps://www.spreaker.com/episode/s2-e17-navigating-through-capa--51979108https://api.spreaker.com/episode/51979108Tue, 22 Nov 2022 12:36:01 +0000Qmed ConsultingIn 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...1131capaclean2fullhttps://www.spreaker.com/episode/s2-e16-the-clinical-evaluation-pathway--51463451https://api.spreaker.com/episode/51463451Tue, 04 Oct 2022 09:34:06 +0000Qmed ConsultingIn 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...2998clean2fullhttps://www.spreaker.com/episode/s2-e15-the-ivdr-transition--51113986https://api.spreaker.com/episode/51113986Fri, 02 Sep 2022 07:29:42 +0000Qmed ConsultingIn 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....3069clean2fullhttps://www.spreaker.com/episode/s2-e14-how-to-eudamed--51024833https://api.spreaker.com/episode/51024833Thu, 25 Aug 2022 08:42:33 +0000Qmed ConsultingThis 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.1021clean2fullhttps://www.spreaker.com/episode/s02e13-conducting-clinical-studies-at-hospitals--49568060https://api.spreaker.com/episode/49568060Wed, 27 Apr 2022 11:13:21 +0000Qmed ConsultingIn this episode, Helene Quie discusses the topic "Conducting Clinical Studies in Hospitals" with study nurse, Christina Møller.1515clean2fullhttps://www.spreaker.com/episode/s02e12-submissions-in-norway--49198603Clinical 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.]]>https://api.spreaker.com/episode/49198603Fri, 25 Mar 2022 13:22:02 +0000Qmed ConsultingIn 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...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.]]>810clean2fullhttps://www.spreaker.com/episode/s02e11-submissions-in-denmark--48997601https://api.spreaker.com/episode/48997601Tue, 08 Mar 2022 21:13:02 +0000Qmed ConsultingIn this episode we discuss submissions in Denmark with Clinical Specialist, Christina Duun Nielsen1090clinicalresearch,healthcare,medical,medtech,submissionsclean2fullhttps://www.spreaker.com/episode/s02e10-market-access-with-soren-underbjerg--46654761https://api.spreaker.com/episode/46654761Mon, 27 Sep 2021 09:28:29 +0000Qmed ConsultingIn this episode, we are joined by Qmed’s market access expert Søren Underbjerg, to discuss the key elements for developing market access strategies.1448access,device,market,medical,qmedclean2fullhttps://www.spreaker.com/episode/s02e09-an-update-on-eudamed-w-richard-houlihan--45291430https://api.spreaker.com/episode/45291430Mon, 14 Jun 2021 09:00:09 +0000Qmed ConsultingRichard 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...2125eudamed,qmedclean2fullhttps://www.spreaker.com/episode/s02e08-how-to-prepare-for-the-upcoming-changes-with-norway-health-tech--44315012https://api.spreaker.com/episode/44315012Tue, 13 Apr 2021 10:27:04 +0000Qmed ConsultingIn 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.901consulting,faust,health,helene,kami,norway,qmed,quie,techclean2fullhttps://www.spreaker.com/episode/s02e07-with-lasse-staal-from-addifab--43891418https://api.spreaker.com/episode/43891418Tue, 16 Mar 2021 10:00:22 +0000Qmed ConsultingIn this episode we are joined by Lasse Staal, CEO of Danish 3D-Printing Pioneer, AddiFab, to talk about 3D-printing of medical devices.2981clean2fullhttps://www.spreaker.com/episode/s02e06-with-ernesto-nogueira-from-valueconnected--43599047https://api.spreaker.com/episode/43599047Wed, 24 Feb 2021 10:00:18 +0000Qmed ConsultingIn this episode of The Qmed Podcast we're joined by Ernesto Nogueira, to talk about Artificial intelligence in the medical device industry.2457clean2fullhttps://www.spreaker.com/episode/s02e05-with-rasmus-lou-moeller-from-meggitt-denmark--43495117https://api.spreaker.com/episode/43495117Wed, 17 Feb 2021 10:00:13 +0000Qmed ConsultingThe 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...1259helenequie,meggitt,qmed,qmedconsulting,rohsclean2fullhttps://www.spreaker.com/episode/s02e04-with-monir-el-azzouzi-from-easy-medical-device--43107990https://api.spreaker.com/episode/43107990Wed, 27 Jan 2021 09:00:09 +0000Qmed ConsultingClinical 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...3163clean2fullhttps://www.spreaker.com/episode/s02e03-with-david-rutledge-from-global-strategic-solutions--27983570
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.]]>https://api.spreaker.com/episode/27983570Fri, 22 May 2020 04:00:02 +0000Qmed ConsultingHad 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...
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.]]>3720clean2fullhttps://www.spreaker.com/episode/s02e02-with-victor-staalkjaer-and-andreas-tuxen-from-june-systems--26861969
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 of EQMS.]]>https://api.spreaker.com/episode/26861969Fri, 08 May 2020 04:00:11 +0000Qmed ConsultingStarting 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,...
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 of EQMS.]]>1717clean2fullhttps://www.spreaker.com/episode/s02e01-with-bjorn-broby-from-neurescue--25844129Questions 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.]]>https://api.spreaker.com/episode/25844129Fri, 24 Apr 2020 04:00:09 +0000Qmed ConsultingOne 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...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.]]>2081clean2fullhttps://www.spreaker.com/episode/the-qmed-podcast-10-with-helene-quie--18334296https://api.spreaker.com/episode/18334296Fri, 21 Jun 2019 04:04:15 +0000Qmed ConsultingIn 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...5196helene,qmed,quieclean1fullhttps://www.spreaker.com/episode/the-qmed-podcast-9-with-heidi-m-mehrzad--18263819https://api.spreaker.com/episode/18263819Fri, 14 Jun 2019 04:00:21 +0000Qmed ConsultingHuman 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...5381clean1fullhttps://www.spreaker.com/episode/the-qmed-podcast-8-with-richard-houlihan--18178626https://api.spreaker.com/episode/18178626Fri, 07 Jun 2019 04:00:04 +0000Qmed ConsultingIn 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...1699eudamed,qmedclean1fullhttps://www.spreaker.com/episode/the-qmed-podcast-7-with-charlotte-piester--18121941https://api.spreaker.com/episode/18121941Fri, 31 May 2019 04:00:07 +0000Qmed ConsultingIn 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...1310device,mdr,medical,qmedclean1fullhttps://www.spreaker.com/episode/the-qmed-podcast-6-with-ernesto-nogueira--18042974
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.]]>https://api.spreaker.com/episode/18042974Fri, 24 May 2019 04:00:05 +0000Qmed ConsultingIn 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...
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.]]>1909clean1fullhttps://www.spreaker.com/episode/the-qmed-podcast-5-with-dr-bassil-akra--17878936https://api.spreaker.com/episode/17878936Fri, 10 May 2019 04:00:23 +0000Qmed ConsultingIn 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...2888clean1fullhttps://www.spreaker.com/episode/the-qmed-podcast-4-with-sandra-ferretti--17802351https://api.spreaker.com/episode/17802351Fri, 03 May 2019 04:00:09 +0000Qmed ConsultingIn 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.2574device,eudamed,mdr,medical,qmedclean1fullhttps://www.spreaker.com/episode/the-qmed-podcast-3-with-gert-andersen--17744655https://api.spreaker.com/episode/17744655Fri, 26 Apr 2019 04:00:04 +0000Qmed Consulting2987clean1fullhttps://www.spreaker.com/episode/the-qmed-podcast-2-with-semih-oktay--17688301https://api.spreaker.com/episode/17688301Fri, 19 Apr 2019 09:07:27 +0000Qmed ConsultingIn 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...4491clean1fullhttps://www.spreaker.com/episode/the-qmed-podcast-1-with-hilde-viroux--17579999https://api.spreaker.com/episode/17579999Tue, 09 Apr 2019 12:41:27 +0000Qmed ConsultingIn 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.4239device,health,medical,qmedclean1full