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USC APEC Medical Device training

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    • Medical Devices training - Spring 2019
    • Regulatory Harmonization - April 2021

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    Medical Devices 2021:
     Regulatory Harmonization of Non-Clinical
    and Clinical Development

    Click a title to view recording

    Interactive sessions

    ​Definitions and Classification

    April 6

    ​Conformity Assessment and Standards

    April 7

    ​Safety, Performance, and Risk

    April 8

    Symposium:  Principles of Global Clinical Research for Medical Devices
    April 9

    1. Introduction and Poll

    2. Clinical Investigation – IMDF guidance document

    3. GCP - ISO 14155

    4. From Clinical Data to Clinical Evidence

    5. Developing Clinical Evaluations + wrap up

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