• Search BSI
  • Verify a Certificate
BSI Home page
Contact Us
Search Icon
Back to menu Choose a country/region

No countries/regions found

Suggested region and language based on your location

    Your current region and language

    Submit
    Medical professionals at table
    • Webinar
      Medical Devices

    Clinical Evaluation of Orphan Devices & MDCG 2024-10

    BSI’s interpretation of the guidance and provide manufacturers with practical help on how to apply for a conformity assessment of an orphan device.

    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

    Presenter information

    Speaker

    Richard Holborow, Head of Clinical Compliance
    Insights & Media

    Insights from our medical devices experts

    Get Insights & Media
    Contact Us

    Let's shape your organization's future together

    Reach out and see how we can help guide you on your path to sustainable operational success.

    Get in touch
    Get in touch