At 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.

As 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.

We 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.

During 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.

We 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.

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.

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.

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.

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 QmedPodcast@gmail.com.

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.

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.

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!

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

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!

Have 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.

In 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.

In 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.

In 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.

In 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.