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    Introduction to ISO 14971:2019

    STANDARDI
    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.

    Inhalt

    • 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
    Registrieren

    Trainer

    Terhi Heikkinen
    Terhi Heikkinen
    Quality & Regulatory Affairs Manager
    terhi.heikkinen@aurevia.com
    Terhi is a medical device professional with over 20 years of experience in product development, quality, and regulatory affairs as well as quality management system development. She has held responsibilities for building or improving QMS and technical documentation to enable QMS certification or product registration. Terhi has an extensive experience in project design control, risk management, verification and validation activities, CE and 510(k) submissions, and ISO 13485, EU MDR, EU IVDR, and FDA quality system requirements and their implementation.

    Zielgruppe

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

    Nach diesem Training

    • 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)

    Hinweis

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

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    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.

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    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.