Suggested region and language based on your location

    Your current region and language

    ISO 13485: 2016

    Universitair Medisch Centrum Utrecht
    Afd. Digital Health
    Heidelberglaan 100
    3584 CX Utrecht
    The Netherlands
    BSI logo

    Certificate Number: MD 811210
    Scope: Design and development, manufacture, and maintenance of software as a medical device for clinical decision support, monitoring, medical imaging analysis, and personalised medicine.

    Original Registration Date Effective Date Last Revision Date Expiry Date
    2025-06-24 2025-06-24 2025-06-24 2028-06-23