The Qmed Podcast

BONUS EPISODE: Structured Dialogue: A Conversation with TÜV SÜD

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-S

BONUS EPISODE: Structured Dialogue: A Conversation with TÜV SÜD

S5 E8: Academy Talks: Medical Device Documentation: Post Market Surveillance

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

S5 E7: Academy Talks: Medical Device Documentation: Clinical Studies

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 diff

S5 E6: Academy Talks: Medical Device Documentation: Pre-clinical testing, Verification and Validation

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 usabili

S5 E5: Academy Talks: Medical Device Documentation: Clinical Evaluation

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 proc

S5 E4: Academy Talks: Medical Device Documentation: Risk Management

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 sev

S5 E3: Academy Talks: Medical Device Documentation: Requirement Specifications

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 p

S5 E2: Academy Talks: Medical Device Documentation: User Need

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. W

S5 E1: Academy Talks: Medical Device Documentation: Stand Alone 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

Academy Talks: Medical Device Documentation

S4_E2_PMCF survey with CETAS Healthcare

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.

S04 E01 Biocompatibility with Ted Heise

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 regula

S03 E05 - Usual Audit Findings During Medical Device Clinical Studies w. Rikke Boege

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 Res

S03 E04 - Clinical Investigations w. Susanne Dr. Gerbl-Rieger

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

S03 E03 - The Benefit-To-Risk Assessment w. David Rutledge

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 w

S03 E02 - Digital Health & Reimbursement

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 dig

S3 E01 - Sufficient Clinical Evidence

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

S2 E18 – The Risk-Based Approach in Risk Management

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 approach

S2 E17 – Navigating Through CAPA

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, r