Zenith Dental Receives ISO 13485 Certification

Zenith Dental Receives ISO 13485 Certification

Englewood, NJ (March 27, 2008) – Zenith Dental, the visionary company with a 25 year tradition of introducing innovative and reliable restorative dental products and exclusive distributor of DMG-manufactured products, announced today that it has achieved International Organization for Standardization (ISO) 13485 certification. 

Published in 2003, ISO 13485 is an ISO standard that represents the requirements for a comprehensive management system for the design and manufacture of medical devices.  The new certification signifies Zenith’s compliance with quality management system (QMS) standards related to medical devices.

Under the certification, Zenith Dental has implemented and maintained a QMS, and has met additional requirements for process control, retention of records, accountability, traceability, and customer satisfaction.  Additionally, ISO 13485 requires that companies demonstrate the ability to supply medical devices and related services that meet client expectations and comply with regulatory requirements. 

The certification has reinforced the vision of the company to provide quality professional products and services in order to meet the ever-changing needs of its clients. 

“This certification applies specifically to medical devices, but I think it is another example of how seriously Zenith Dental considers our business and our dedication to clients,” remarked George Wolfe, Zenith Dental President.  “We are committed to quality within our organization and meeting all requirements applicable to the healthcare industry.” 

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