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    Trainings

    Clinical Research under MDR and ISO 14155:2020

    MEDICAL DEVICES

    A one-day intensive training about all related matters regarding clinical research aspects with medical devices, including a practical workshop.

    Topics of this session

    • Medical Device Regulation 2017/745 (MDR), MDCG documents, ISO 14155:2020, Declaration of Helsinki, GDPR
    • Submission to Ethic Committees, Competent Authorities
    • Conducting the clinical investigation, documentation, risk-based monitoring, informed consent
    • Safety in clinical investigations, reporting obligations, corrective actions
    • Noncompliance, Audits and Inspections, frequent problems
    • Workshop: development of a concept for a clinical investigation
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    Trainers

    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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    Regulatory Essentials in Health Tech: Clinical Evaluation in Practice
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    Clinical evaluation of medical devices according to MDR & MEDDEV 2.7/1 Rev. 4
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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.