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    • Webinar
      Medical Devices

    Clinical Evaluation of Orphan Devices & MDCG 2024-10

    The European Commission have recently released MDCG guidance (MDCG 2024-10) to help support the clinical evaluation of orphan devices.

    Watch the Webinar View the Presentation

    Help on how to apply for a conformity assessment of an orphan device.

    You will gain an understanding of the MDCG guidance and will be aware of the process to apply to BSI with a device that qualifies to the criteria.

    • What defines a medical device as an Orphan Device (OD)?

    • What is expected of manufacturers?

    • Considerations and Limitations when documenting a Clinical Evaluation on Orphan Devices.

    • The Role of Pre-Clinical Data.

    Speakers

    Hear from these experts in this webinar

    Speaker

    Richard Holborow

    Head of Clinical Compliance, BSI

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