LANSDALE, PA — X-Nav Technologies, LLC, has announced that its X-Guide® Dynamic 3D Surgical Navigation System is the first of its kind to receive certification under the European Union Medical Device Regulation 2017/745, also known as EU MDR. This marks a significant milestone for the Pennsylvania-based company, cementing its position as an industry leader in dental surgical technology.
EU MDR is recognized as one of the most stringent medical device regulations worldwide, designed to ensure superior safety and quality standards in the development and manufacturing of medical devices for the European market. The process involves a comprehensive audit of a company’s Technical Documentation, Clinical Evidence, and Quality Management System.
The certification verifies that the X-Guide System delivers the claimed clinical benefits for dental surgical procedures, including dental implant surgery and endodontic access. It underscores X-Nav’s commitment to quality, safety, and performance in all its products and processes.
Kimberly Chan, Director of Regulatory Affairs and Quality Assurance at X-Nav Technologies, commented on the achievement, saying: “This certification reflects our high standards and dedication to quality. We’re proud to be among the top medical device companies capable of meeting this regulation.”
With the EU MDR certification, X-Nav is uniquely positioned to support its European customers, partners, and patients with hardware, software, and feature updates. It also paves the way for the company to deliver future innovations that will drive value for its customers.
Edward Marandola, President and CEO of X-Nav Technologies, lauded the efforts of the in-house team in securing the certification. He said, “This milestone reflects our commitment as a global leader in delivering high-quality and innovative medical devices. It sets us up to deliver our roadmap of future surgical solutions.”
The X-Guide Surgical Navigation System, an industry-leading tool used by dentists and clinicians globally, allows for more accurate and less invasive dental surgical procedures. Available in over 50 countries and 23 languages, the system holds 31 trademarks and over 50 patents and is used by more than 50 universities worldwide.
The EU MDR certification adds to X-Nav’s portfolio of quality and regulatory accomplishments, demonstrating its commitment to maintaining and exceeding industry standards.
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