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    Regulatory Essentials

    Regulatory Essentials in Health Tech: Risk Management in Practice

    This session provides a practical approach to implementing risk management according to the ISO 14971:2019 standard. Stages of risk management, as well as evaluation principles, are presented.

    The Regulatory Essentials in Health Tech training series consists of 14 1,5-2 hour on-demand webinar sessions. Read more on the complete course page here >>

    Topics

    • Purpose of Risk Management
    • MDR requirements for risk management and ISO 14971 standard
    • Risk management process in practice
      • Risk analysis, estimation, and control
      • Residual risks and risk management report
    • Post-market surveillance
    • Risk-management documents and tools
    • Risk management as a continuous process

    Target group

    All health tech developers and stakeholders interested in gaining specific knowledge on how to apply Risk Management for medical devices. Particular focus on start-up founders and staff, university innovator teams, young health tech professionals, and new employees.

    Objectives

    • Know the essential requirements and terminology regarding the Risk Management of a medical device
    • Know-how to implement Risk Management in practice

    Additional information

    This session is intended to provide a basic understanding of the Risk Management of medical devices. Following the Regulatory Essentials sessions 1-4 prior to this on-demand session is recommended.