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    Regulatory Essentials in Health Tech: Clinical Evaluation in Practice

    REGULATORY ESSENTIALS

    This on-demand session presents the essentials of Clinical Evaluation, including the requirements and guidelines for Clinical Evaluation and the structure of the Clinical Evaluation plan and report. From the perspective of in vitro diagnostics, Performance Evaluation is also reviewed. Clinical Evaluation for medical device software is also briefed, as well as conducting a literature report.

    The Regulatory Essentials in Health Tech training series consists of 14 1,5-2 hour on-demand webinar sessions. Read more on the complete course page here >>

    Topics of this session

    • Purpose of Clinical Evaluation
    • Requirements and guidelines
    • Structure of Clinical Evaluation plan and report
    • Claims and clinical benefits of your device
    • Establishing “state of the art”
    • Gathering and assessing clinical data
    • Clinical Evaluation for Medical Device Software
    • Conducting and documenting literature and database searches
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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

    All health tech developers and stakeholders interested in gaining specific knowledge on how to apply Clinical Evaluation for medical devices. Particular focus on start-up founders and staff, university innovator teams, as well as young health tech professionals and new employees.

    After this session, you

    • Understand the fundamental requirements for Clinical Evaluation of medical devices and Performance Evaluation of in vitro diagnostics.
    • Understand the relationship of Clinical Evaluation to Risk Management and Post-Market Surveillance.

    Notice

    This on-demand session is intended to provide a basic understanding of the Clinical Evaluation of medical devices. It is recommended to follow the Regulatory Essentials sessions 1-4 as well as session 7 (Risk Management) before this on-demand session.

    What next?

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    Regulatory Essentials in Health Tech - Full Training Series
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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.