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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

    Get in touch

    Whether you're starting the certification process, looking to transfer or just need to discuss options for your business, we can help.

    Get in touch