In 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.

In 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.

In 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.

In 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.

In 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.

In 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.

In 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.

In this episode, we are joined by Qmed’s market access expert Søren Underbjerg, to discuss the key elements for developing market access strategies.

In this episode, Helene Quie discusses the topic “Conducting Clinical Studies at Hospitals” with study nurse, Christina Møller.

This 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.

In 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.

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.

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 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 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.

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.

I am interviewing David Ruthledge on the topic Benefit Risk Assessment. David gives practical insight on how to set up and run the process. We also discuss how to use the data to the benefit of achieving better and safer products.

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.

In our first episode of our new Academy Talks series on Medical Device Documentation, we 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.

In our latest episode of the Qmed Podcast Academy Talks Series on Medical Device Documentation, Helene Quie and Søren Underbjerg continue discussing the development of the device description.

We define our intended user and patient population, talk about what input sources to use and discuss how to create the specific documentation. We will also touch on how concept testing can be used to develop the early stage documents and walk you through how to update your user input documents.

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.

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.

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.

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 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.

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.