The Qmed Podcast

Qmed Consulting
  • 0,0 (0)
  • Medizin
  • Monatlich

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.

  1. 22.01.2025

    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-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.

    22 Min.

  2. 13.12.2024

    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 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.

    9 Min.

  3. 06.12.2024

    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 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.

    20 Min.

  4. 29.11.2024

    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 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.

    17 Min.

  5. 22.11.2024

    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 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.

    25 Min.

  6. 15.11.2024

    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 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.

    21 Min.

  7. 08.11.2024

    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 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.

    17 Min.

  8. 01.11.2024

    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. 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.

    17 Min.
Alle anzeigen (45)

Info

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.

Informationen

  • Erstellt von
    Qmed Consulting
  • Jahre aktiv
    2019 - 2025
  • Folgen
    45
  • Bewertung
    Unbedenklich
  • Copyright
    © Copyright Qmed Consulting
  • Sendungswebsite
    The Qmed Podcast