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    Medical devices

    Introduction to ISO 13485 Standard

    This training provides an overview of the ISO 13485:2016 quality management system standard and its requirements. The training includes small-group discussions and interactive exercises using various tools.

    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

    • 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

    Trainers

    Leena Raunio
    Leena Raunio
    Quality and Regulatory Affairs Manager
    Leena Raunio is a medical device professional with over 20 years of experience within the industry. She has held senior managerial positions in quality and regulatory management and has hands-on experience in building, running, and auditing quality management systems (ISO 13485, MDR, FDA QSR). She is a certified ISO 13485 and MDSAP lead auditor. 

    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.

    Objectives

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

    Additional information

    The course is held online. Course material is in English, with verbal presentation and discussions in English or Finnish depending on the participants. 

    Cancellations must always be communicated to academy@aurevia.com and confirmed by us. Cancellations made more than 4 weeks before the starting date are free of charge. Cancellations made 2-4 weeks before the starting date of the event will be refunded by 50%. Cancellations made less than 2 weeks before the starting date of an event will not be refunded. If you are unable to attend, substitution with a colleague is possible and recommended. Aurevia reserves the right to cancel the course due to low attendance, up until 2 weeks before the course start. You can contact us at any time to get a status update. If the course is cancelled, a full course fee refund will be offered, but no additional reimbursements. We reserve the right to change the agenda, time and location, up until 2 weeks before the course. Aurevia reserves the right to change teachers or reschedule the course due to force majeure or due to teacher’s illness. No compensation will be paid for any additional costs incurred.

    Related courses

    ISO 13485 standard internal auditing
    In this two-day course, you will gain fundamental knowledge of the concept of auditing, its scope, and procedures, as well as the skills and qualifications to function as an internal auditor in accordance with the ISO 13485:2016 standard within your own organization.