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.
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
Emergo Australia
201 Sussex Street
Darling Park, Tower II,
Level 20
Sydney, NSW, 2000
Australia
Telephone: +61-2-9006-1662
Emergo Europe BV
Westervoortsedijk 60
6827 AT Arnhem
The Netherlands
Telephone: +31 (0) 70 345 8570
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.