Regulatory Essentials in Health Tech: Usability and Labelling
This on-demand 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 1,5-2 hour on-demand webinar sessions. Read more on the complete course page here >>
Topics of this session
- 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
- Instructions for Use and other labelling
- Use of symbols
- Unique Device Identifier (UDI)
- Marketing claims
Terhi HeikkinenQuality & Regulatory Affairs Manager
Karri AirolaSenior Expert, Regulations, Quality & Training
”I have more than twenty years of experience in 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 the 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 my 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.”
Target groupAll health tech developers and stakeholders interested in gaining specific knowledge on how to apply the Usability and Labelling requirements on medical devices. Particular focus on start-up founders and staff, university innovator teams, young health tech professionals and new employees.
After this session, you
- Understand the requirements and value of Usability Engineering as an essential part of medical device development.
- Understand the principles of user interface design.
- Are aware of the labeling requirements applicable to all medical devices by various regulations.
NoticeIt is recommended to follow the Regulatory Essentials sessions 1-4 before this on-demand session.
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: firstname.lastname@example.org.
The participating organization may, if it wishes, change the participant free of charge by notifying it in writing before the event to: email@example.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.