Quality Management System
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 Regulatory Representatives
X-Nav Technologies, LLC.
1555 Bustard Road, Suite 75
Lansdale, PA 19446
AUSTRALIA – Sponsor
201 Sussex Street
Darling Park, Tower II,
Sydney, NSW, 2000
EUROPE – Authorized Representitive
2514 AP The Hague
UNITED KINGDOM – Responsible Person
Emergo Consulting (UK) Limited
c/o Cr360 – UL International
Compass House, Vision Park Histon
Cambridge CB24 9BZ
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 IS EN 62471-1.