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    A group of medical staff are indoors in a hospital. They are wearing medical clothing. A doctor is giving a presentation to the others.
    Regulatory Services

    How We Work With Our Medical Device Clients

    BSI works with many of the largest medical device companies in the world.

    What We Offer You

    Maintaining quality and delivering excellence, BSI offers certification services to place safe and compliant medical devices on the market.

    We are:

    • A designated EU Notified Body
    • A UK Approved Body
    • An accredited ISO 13485 Certification Body
    • A recognized Auditing Organization under the Medical Device Single Audit Program (MDSAP)
    • A recognized Certification Body in many global markets
    Regulatory Services

    Combined Expertise and Solutions

    Our regulatory services combined with our world-leading experience provide efficient pathways to place your device on the market.

    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