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 >>Jetzt registrieren
Regulatory Essentials in Health Tech: Usability and Labelling
Inhalt
- 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
Trainer
”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.”
Zielgruppe
All 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.Nach diesem Training
- 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.
Hinweis
It is recommended to follow the Regulatory Essentials sessions 1-4 before this on-demand session.What next?
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Lesen Sie hier die Abrechnungs- und Stornierungsbedingungen für Online-Schulungen.
Die Teilnahme an der Schulung kann zwei Wochen (14 Tage) vor der Veranstaltung kostenfrei storniert werden. Bei Stornierungen, die danach erfolgen, berechnen wir 50 % der Teilnahmegebühr, bei Stornierungen, die eine Woche vor der Veranstaltung erfolgen, berechnen wir 100 % der Teilnahmegebühr.
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