Regulatory Essentials in Health Tech – Session 9: Usability and Labelling


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

The Regulatory Essentials in Health Tech training series consists of 14 webinar sessions, 2,5h each.
Read more on the complete course page here.


 

SPRING 2022
Time: 28.4.2022 at 10.00-12.30 (EET)
Place: Online
Price: 250€ + VAT 24%

AUTUMN 2022
Time: 27.9.2022
Place: Online
Price: 250€ + VAT 24%

 

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.

Trainers:


Karri: 
”I have more than twenty years of experience from the Medical Device industry in various positions, with responsibilities for leading a quality assurance team and overall regulatory compliance according to the ISO 13485 standard, Brazilian (ANVISA), Australian (TGA), US FDA and the EU MDR requirements. I have also worked in the Management Representative role for various companies and most recently as a Person Responsible for Regulatory Compliance (PRRC).

My responsibilities have also spanned design and development of new Medical Devices, their immaterial property rights (IPR) and supply management. I have worked in start-ups and growth companies for most of his career, holding also the role of a co-founder, which has provided me with a wide perspective into the challenges that young companies face on their way to the international market.”


Ilona:
 ”I have worked in regulatory compliance positions for 15 years. Prior to stepping into the Medical Device field, I held responsibilities in consumer electronics and environmental and material compliance and continue to advise manufacturers on those topics. For the past seven years, I have been guiding various health tech companies with Medical Device regulations. My experience ranges from the compliance of artificial intelligence (AI) medical software to hands-on clinical evaluation, and from setting up and auditing ISO 13485 compliant quality management systems to enabling the international market access for several types of health technology.”

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
      • Use of symbols
      • Unique Device Identifier (UDI)
      • Marketing claims

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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