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    Two women consulting reports
    • Webinar
      Medical Devices

    Understanding Periodic Safety Update Reports and submitting to BSI

    Understanding Periodic Safety Update Reports and how to submit your PSUR to BSI

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    Understanding Periodic Safety Update Reports

    Provides manufacturers with an understanding of BSI expectation in relation to PSURs and provide an overview of the recent guidance related to PSURs.

    • An understanding of BSI expectations in relation to PSUR.

    • An overview of MDCG 2022-25.

    • How to correctly submit PSURs to the notified body.

    • When to submit SSCPs alongside PSURs.

    Understanding Periodic Safety Update Reports and submitting to BSI

    Manufacturers will understand BSI's expectation in relation to PSURs and provide an overview of the recent guidance related to PSURs (MDCG 2022-21).

    Richard Holborow, Head of Clinical Compliance, BSI

    Maddalena Pinsi, Regulatory Lead, BSI
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