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    Regulatory Essentials in Health Tech: Usability and Labelling

    REGULATORY ESSENTIALS

    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 >>

    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
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    Trainer

    Terhi Heikkinen
    Terhi Heikkinen
    Quality & Regulatory Affairs Manager
    terhi.heikkinen@aurevia.com
    Terhi is a medical device professional with over 20 years of experience in product development, quality, and regulatory affairs as well as quality management system development. She has held responsibilities for building or improving QMS and technical documentation to enable QMS certification or product registration. Terhi has an extensive experience in project design control, risk management, verification and validation activities, CE and 510(k) submissions, and ISO 13485, EU MDR, EU IVDR, and FDA quality system requirements and their implementation.
    Karri Airola
    Karri Airola
    Senior Expert, Regulations, Quality & Training
    karri.airola@aurevia.com

    ”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.

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    RECHNUNGS- UND STORNIERUNGSBEDINGUNGEN

    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.

    Stornierungen erfolgen immer schriftlich an: koulutus@aurevia.com.  
    Die teilnehmende Organisation kann den Teilnehmer auf Wunsch kostenlos wechseln, indem sie dies vor der Veranstaltung schriftlich an:  koulutus@aurevia.com meldet. Die Teilnahmegebühr wird unmittelbar nach der Veranstaltung in Rechnung gestellt. Die Trainingseinheit wird dem Teilnehmer ca. eine Woche vor der Veranstaltung per E-Mail bestätigt. Labquality behält sich das Recht vor, die Schulung aufgrund einer zu geringen Teilnehmerzahl abzusagen.