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    Regulatory Essentials

    Regulatory Essentials in Health Tech: Post-Market Surveillance and Clinical Follow-up

    This on-demand session gives a basic understanding of the regulation of Post-Market Surveillance (PMS) and the mandatory PMS documentation, such as the Periodic Safety Update Report (PSUR) and Summary of Safety and Clinical Performance (SSCP).

    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 and definitions of PMS and PMCF
    • MDR requirements and guidelines
    • How to gather data and identify data gaps
    • PMS process and plan
    • Trend reporting
    • When and why to conduct a PMCF study
    • PMS and PMCF in relation to Clinical Evaluation
    • PMS report, Periodic Safety Update Report (PSUR) and Summary of Safety and Clinical Performance (SSCP)

    Target group

    All health tech developers and stakeholders interested in gaining specific knowledge on how to take into consideration the Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) requirements for medical devices and in-vitro diagnostics to remain in compliance throughout the device life-cycle. Special focus on start-up founders and staff, university innovator teams as well as young health tech professionals and new employees.

    Objectives

    • Understand the fundamental requirements for post-market surveillance for all types of medical devices.
    • Understand the relationship of Post-Market Surveillance to Clinical Evaluation, Risk Management, and business in the long term.

    Additional information

    It is recommended to follow the Regulatory Essentials sessions 1-4 as well as sessions 8 (Risk Management) and 11 (Clinical Evaluation) before this on-demand session.