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Ready 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...
mostra más
Ready 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 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.
mostra menos
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.
15 NOV. 2024 · This 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.
8 NOV. 2024 · Now 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.
1 NOV. 2024 · We 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.
25 OCT. 2024 · In 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 mailto:QmedPodcast@gmail.com.
23 OCT. 2024
8 FEB. 2024 · During 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.
13 ENE. 2024 · Ted 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.
1 DIC. 2023 · I 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!
3 NOV. 2023 · During 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
29 SEP. 2023 · In 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!
Ready 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...
mostra más
Ready 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 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.
mostra menos
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.
Información
| Autor | Qmed Consulting |
| Organización | Qmed Consulting |
| Categorías | Salud y forma física , Medicina |
| Página web | www.qmed-consulting.com |
| qmedpodcast@gmail.com |
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