<img alt="" src="https://secure.52enterprisingdetails.com/787780.png" style="display:none;">
Skip to content
    Hero Image
    Medical devices

    Introduction to ISO 14971:2019

    This training provides an overview of the ISO 14971 risk management standard and its requirements.
    ISO 14971:2019 sets out international requirements for risk management procedures for healthcare devices and supplies throughout all stages of their lifecycle. The standard ensures that medical devices entering the market are both safe and effective.

    This training provides an overview of the ISO 14971 risk management standard and its requirements. You will gain an understanding of the importance of risk management for the safety of medical devices, learn how to apply the standard’s requirements in practice, and discover appropriate methods for risk management activities. The training also covers the requirements placed on risk management by EU legislation (MDR 2017/745, IVDR 2017/746) and touches on other essential standards and guidelines related to medical device risk management.

    Topics

    • Basic concepts of risk management
    • General requirements of ISO 14971:2019
    • EU legislation (MDR 2017/745 and IVDR 2017/746) requirements for risk management
    • Risk management plan
    • Risk analysis, evaluation, and control
    • Benefit-risk analysis and evaluation of residual risk
    • Risk acceptability criteria
    • Risk management report
    • Post-production monitoring from a risk management perspective
    • Specific features of risk management for IVD products
    • Specific features of risk management for medical softwareISO/TR 24971:2020 and other relevant standards and guidelines

    Target group

    Professionals working with healthcare devices and supplies, quality managers, and those responsible for product development and risk management.

    Objectives

    • You will have a good overall understanding of the ISO 14971:2019 risk management standard and its requirements
    • You will understand the significance of risk management from the perspective of medical device quality
    • You will be able to apply the standard’s requirements in practice
    • You will know how to address the additional risk management requirements imposed by EU legislation (MDR 2017/745, IVDR 2017/746)

    Additional information

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