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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.

    Topics of this session

    • 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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    Trainers

    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.

    Target group

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

    After this session, you

    • 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

    Notice

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

    What next?

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    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: koulutus@aurevia.com.  
    The participating organization may, if it wishes, change the participant free of charge by notifying it in writing before the event to:  koulutus@aurevia.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.