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    Regulatory Essentials

    Regulatory Essentials in Health Tech: Clinical Evaluation in Practice

    This on-demand session presents the essentials of Clinical Evaluation, including the requirements and guidelines for Clinical Evaluation and the structure of the Clinical Evaluation plan and report. From the perspective of in vitro diagnostics, Performance Evaluation is also reviewed. Clinical Evaluation for medical device software is also briefed, as well as conducting a literature report.

    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 Clinical Evaluation
    • Requirements and guidelines
    • Structure of Clinical Evaluation plan and report
    • Claims and clinical benefits of your device
    • Establishing “state of the art”
    • Gathering and assessing clinical data
    • Clinical Evaluation for Medical Device Software
    • Conducting and documenting literature and database searches

    Target group

    All health tech developers and stakeholders interested in gaining specific knowledge on how to apply Clinical Evaluation for medical devices. Particular 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 Clinical Evaluation of medical devices and Performance Evaluation of in vitro diagnostics.
    • Understand the relationship of Clinical Evaluation to Risk Management and Post-Market Surveillance.

    Additional information

    This on-demand session is intended to provide a basic understanding of the Clinical Evaluation of medical devices. It is recommended to follow the Regulatory Essentials sessions 1-4 as well as session 7 (Risk Management) before this on-demand session.