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    Regulatory Essentials in Health Tech: Clinical Investigations in Practice

    REGULATORY ESSENTIALS

    Conducting a well-designed clinical investigation is undoubtedly the best way to produce information on the safety and performance of a medical device. Clinical investigations or studies can be demanding, and they often require several stakeholders from statisticians to health care professionals. Planning of clinical investigation should be part of the early development of a medical device to best comply with the requirements. Practical considerations related to the clinical investigation of medical devices are summarized in this session.

    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

    • Identifying and verifying the need for a clinical investigation.
    • Defining the requirements and prerequisites for a clinical investigation.
    • Regulation (MDR), national law(s), and ISO 14155:2020 requirements.
    • Compiling and assessing a Clinical Investigation Plan (CIP).
    • Mandatory processes and documentation.
    • Needed approvals from authorities and preparation of applications.
    • Roles and responsibilities & facilities.
    • Budgeting and monitoring of a clinical investigation.
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    Trainers

    Hanna Marttila
    Hanna Marttila
    Senior Advisor, Clinical Studies
    hanna.marttila@aurevia.com

    Hanna Marttila is the Senior Advisor for Clinical Studies in Labquality's CRO business. She has over 25 years of experience in the life sciences sector, both in the public and private sectors. Hanna has strong expertise in clinical studies (drugs and medical devices) in both commercial and academic settings, where she has held various roles. Her work experience in regulatory roles related to medical devices and in drafting international marketing authorization applications has given her a comprehensive understanding of business practices and the application of laws and regulations.

    Target group

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

    After this session, you

    • Know the regulatory considerations on clinical investigations.
    • Are aware of the stages of a clinical investigation project.
    • Understand the necessary roles in clinical investigations.
    • Are aware of the approval practices related to clinical investigations.

    Notice

    This on-demand session is intended to provide a basic understanding of Clinical Investigation practices for medical devices. It is recommended to follow the Regulatory Essentials sessions 1-4, session 8 for Risk Management, and session 11 for Clinical Evaluation before this on-demand session.

    What next?

    You might also be interested in 

    Regulatory Essentials in Health Tech - Full Training Series
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    Clinical Research under MDR and ISO 14155:2020
    A one-day intensive training about all related matters regarding clinical research aspects with medical devices, including a practical workshop.
    Read more

    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.