Quality Management System

News! X-Guide Is The First Dental Surgical Navigation System To Receive European Union Medical Device Regulation 2017/745, commonly referred to as EU MDR

Global achievement signifies the Company’s commitment to quality and safety, while paving the way to deliver continued innovation and growth for surgeons and patients.

To read the full announcement, click here.

X-Nav Technologies is committed to delivering innovative solutions for the dental market through high quality products and services.

Development, testing, manufacturing, marketing and distribution processes are compliant with relevant regulatory and quality standards set forth by local and global agencies.  

X-Nav Technologies employs rigorous compliance programs to ensure we deliver quality products and services to our customers. 

The company has received clearance to market and sell the X-Guide Dynamic 3D Navigation System to dental clinicians in the United States, Canada, Australia, the European Community, and many more countries. For a full list, please visit our International page.

    Global Quality Regulatory Representatives

    X-Nav Technologies, LLC.
    1555 Bustard Road, Suite 75
    Lansdale, PA 19446
    Telephone: 267-436-0420
    AUSTRALIA – Sponsor
    Emergo Australia
    201 Sussex Street
    Darling Park, Tower II,
    Level 20

    Sydney, NSW, 2000

    Telephone: +61-2-9006-1662
    EUROPE – Authorized Representitive
    Emergo Europe BV
    Westervoortsedijk 60
    6827 AT Arnhem
    The Netherlands
    Telephone: +31 (0) 70 345 8570
    UNITED KINGDOM – Responsible Person
    Emergo Consulting (UK) Limited
    c/o Cr360 – UL International
    Compass House, Vision Park Histon
    Cambridge CB24 9BZ
    United Kingdom
    Telephone: +44(0) 1223 772 671

    X-Nav Technologies, LLC Quality Management System (QMS) has been certified to be compliant with the requirements of ISO 13485:2016 and the applicable MDSAP country regulations, by a reputable registrar. Additionally, X- Nav products have undergone safety certification testing to IEC 60601-1 main standard and applicable collateral standards, including IEC 62471.

    ISO 13485:2016 / MDSAP Certificate

    X-Nav is proud to demonstrate our commitment to quality and best practices in all that we do -

    Business, Regulation, Product, and Services.