Regulatory Essentials in Health Tech – Session 8 Usability and Labelling

This session introduces the essentials for usability and labeling. Usability standard IEC 62366, user interface and human factors are explained. The session includes also compact briefing of essential labeling, such as instructions for use, use of symbols and marketing claims.

The Regulatory Essentials in Health Tech training series consists of eleven 2,5h webinar sessions.
Read more on the complete course here.

Time: 28.9. 2021, at 10.00-12.30
Place:
Teams
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 the Usability and Labelling requirements on 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 the requirements and value of Usability Engineering as an important part of medical device development
  • Understand the principles of user interface design
  • Are aware of the labelling requirements applicable to all medical devices by various regulations

Notice: It is recommended to follow the Regulatory Essentials sessions 1-4 prior to this course.

Kouluttaja:

CONTENT OF THIS SESSION:

    • Usability
      • What are usability, UX and human factors?
      • Why is usability important for medical devices?
      • The IEC 62366 standard on usability
      • User interface design principles
      • Usability engineering process for medical devices
    • Labelling
      • Instructions for Use and other labelling
      • Marketing claims – What can you claim?
      • Use of symbols
      • Unique Device Identifier (UDI)

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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