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    Introduction to the ISO 13485 Standard

    STANDARDI

    ISO 13485:2016 is a globally used management system standard for manufacturers of healthcare devices and supplies, as well as other professionals in the field. The standard ensures that regulatory and customer requirements for healthcare devices and supplies are met at every stage of a product’s lifecycle.

    This training provides an overview of the ISO 13485:2016 quality management system standard and its requirements. You will learn the significance of the standard from the perspective of medical device quality and how to apply its requirements in practice. The training also covers the connection between EU legislation (MDR 2017/745, IVDR 2017/746) and the standard, as well as additional requirements these regulations impose on quality systems.

    Inhalt

    • Concepts of the ISO standard and process-based approach
    • General requirements
    • Documentation requirements
    • Management responsibility
    • Resource management
    • Product design and realization
    • Measurement, analysis, and improvement
    • EU legislation (MDR 2017/745 and IVDR 2017/746) requirements for the quality management system
    • Practical exercises to help understand quality system processes
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    Trainer

    Nina Vartiainen
    Nina Vartiainen
    Senior Specialist
    nina.vartiainen@aurevia.com

    Nina Vartiainen is a biochemist with a PhD in molecular neurobiology. She has over a decade of experience in multinational teamwork and project management in R&D projects. Most recently, she has worked with medical device and laboratory quality management systems. She also has hands-on experience in business development by integrating product development projects with quality and regulatory frameworks.

    Nina Vartiainen on biokemisti, jolla on tohtorin tutkinto molekyylineurobiologiassa. Yli vuosikymmenen kokemus monikansallisesta tiimiyhteistyöstä ja projektinhallinnasta T&K-projekteissa. Viimeksi työskennellyt lääkinnällisten laitteiden ja laboratorioiden laadunhallintajärjestelmien parissa, ja hänellä on omakohtaista kokemusta liiketoiminnan kehittämisestä yhdistämällä tuotekehitysprojekteja laatu- ja sääntelykehykseen.

    Zielgruppe

    Professionals working with healthcare devices, those responsible for developing and maintaining an ISO 13485 quality management system, and anyone interested in this topic.

    Nach diesem Training

    • You will have a good overall understanding of the ISO 13485:2016 quality management system standard and its requirements
    • You will understand the principles of a process-based approach
    • You will understand the importance of the standard from the perspective of medical device quality
    • You will be able to implement the standard’s requirements in practice
    • You will know how to take into account additional requirements introduced by EU legislation (MDR 2017/745, IVDR 2017/746) for the quality management system

    Hinweis

    The training includes small-group discussions and interactive exercises using various tools (e.g., Socrative, Kahoot, Mentimeter).

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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.