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    Medical devices

    Risk management for medical devices

    In this two-day course, you will learn about key risk management concepts and get an overview of the process steps involved according to ISO 14971:2019.
    In this course, you will learn about key risk management concepts and get an overview of the process steps involved according to ISO 14971:2019. You will also learn how risk management practices should be applied throughout a product’s entire life cycle and how it relates to other processes within a quality management system.

    We will highlight specific regulatory requirements that apply to risk management and give you an insight into the increased regulatory focus on risk management in the MDR and the IVDR.

    With hands-on exercises, group discussions and examples, this course will provide the knowledge and skills you need to understand and perform each step of the risk management process. The practical part of the course includes an overview of the most common tools used for risk analysis, some best practices for documenting results, and how to ensure traceability.

    Topics

    • Requirements according to ISO 14971:2019
    • Regulatory requirements according to MDR/IVDR
    • Key concepts and definitions
    • A walk-through of all process steps
    • Methods and tools to support risk analysis
    • Elements of risk management plan, report, file and traceability
    • Integration of risk management into a product’s life cycle and quality management systems

    Trainers

    Cristina Albu Barkman
    Cristina Albu Barkman
    Principal Consultant

    Cristina has a Licentiate degree in Medical Science, as well as a Master’s degree in Electrical Engineering/Biomedical Engineering. With over 25 years of QA/RA experience in the medical device industry, she has worked with both start-ups as well as large international companies. Her expertise spans the entire medical device lifecycle, covering complex systems—including hardware, software, and accessories—as well as single-use devices. For nearly two decades, she has specialized in risk management for medical devices, a field she is deeply passionate about. She supports companies in establishing tailored, efficient risk management processes to ensure device safety. Additionally, she serves as an active expert on national and international standardization committees.

    Target group

    This course is intended for medical device professionals performing or participating in risk management activities and those who need to learn the basics of risk management, as well as and for those who need to refresh their basic knowledge of risk management.

    Objectives

    After the course, participants will have a deep understanding of each step of the risk management process and of the methods and tools to support risk analysis. The participants will be able to perform value adding risk management work at their companies. We recommend that participants are familiar with quality systems requirements for medical devices according to ISO 13485.

    Additional information

    The course costs 9 800 SEK (excluding local VAT). The course material is in English, with verbal presentation and discussions varying between Swedish and English.

    Related courses

    Quality management system according to EN ISO 13485:2016 – in practice
    The two-day course, in cooperation with Intertek Academy, provides a basic understanding of the requirements and how to design, deploy and maintain a working quality management system.