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    Clinical evaluation of medical devices according to MDR & MEDDEV 2.7/1 Rev. 4

    MEDICAL DEVICES

    A one-day intensive training about all related matters regarding the preparation of a clinical evaluation for a medical device including a workshop.

    Topics of this session

    • Medical Device Regulation 2017/745 (MDR), MDCG documents, MEDDEV 2.7/1 rev. 4
    • Basics of clinical evaluation, clinical data, the relationship between PMS/PMCF and clinical evaluation (CEP, CER)
    • Structure and content of a CEP and CER, clinical evaluation process, required documents and data, equivalent, similar and benchmark devices
    • Different ways of clinical evaluation, evidence-based medicine, different types of scientific publications, dealing with problematic data, problem areas: too much or too little clinical data
    • PMS and PMCF, CAPA, clinical evaluation update, risk/benefit ratio
    • Clinical evaluation workshop: Literature research, evaluation of literature, dealing with problem areas
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    Trainers

    Kirsten Sander
    Kirsten Sander
    ARTIMED, Clinical Research Team Lead
    kirsten.sander@aurevia.com
    Kirsten Sander, MSc Biology, is the Clinical Research Team Lead for Labquality’s subsidiary Artimed Medical Consulting GmbH in Germany. She has been working in clinical research for more than 10 years, with experience in medical and scientific writing, monitoring, and project management. She has in-depth knowledge of regulatory requirements for clinical investigations (EU MDR, MDCG, ISO 14155, German MPDG), clinical evaluations, and post-market clinical follow-ups.

    Target group

    People working in clinical research, safety reporting, regulatory affairs, and quality management.

    After this session, you

    • you are familiar with the specific regulatory requirements for clinical investigations with medical devices
    • you can develop a clinical investigation plan and synopsis
    • you know which ethical, scientific and quality aspects need to be considered
    • you will learn in a workshop which problems may arise and how they can be solved
    • you will be able to plan, conduct and evaluate a clinical investigation with a medical device and understand the relevant regulatory requirements

    What next?

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    Billing and cancellation policy

    Read the billing and cancellation policy for online trainings here.

    Participation in the training can be cancelled two weeks (14 days) before the event free of charge. For cancellations made after this, we will charge 50% of the participation fee, except for cancellations made one week before the event, we will charge a 100% participation fee.

    Cancellations are always made in writing to: koulutus@aurevia.com.  
    The participating organization may, if it wishes, change the participant free of charge by notifying it in writing before the event to:  koulutus@aurevia.com. The participation fee will be invoiced immediately after the event. The training session will be confirmed to the participant by e-mail about a week before the event.  Labquality reserves the right to cancel the training session due to a small number of participants.