Regulatory Essentials in Health Tech – Session 10 Clinical Evaluation in Practice

This session presents the essentials of clinical evaluation, including the requirements and guidelines for clinical evaluation as well as structure of Clinical Evaluation plan and report. From the perspective of in vitro diagnostics, Performance Evaluation is reviewed as well. 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 eleven 2,5h webinar sessions.
Read more on the complete course here.

Time: 5.10. 2021, at 10.00-12.30
Place: Zoom
Price: single session 250€ (Prices are VAT 0%)

 

Target Group: All health tech developers and stakeholders interested in gaining specific knowledge on how to apply Clinical Evaluation 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:

  • Understand what are the fundamental requirement for Clinical Evaluation of medical devices and Perfomance Evaluation of in vitro diagnostics
  • Understand the relationship of Clinical Evaluation to Risk Management and Post-Market Surveillance

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

Kouluttaja:

CONTENT 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

BILLING AND CANCELLATION POLICY 
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@labquality.fi.  
The participating organization may, if it wishes, change the participant free of charge by notifying it in writing before the event to: koulutus@labquality.fi. 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.

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