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Press Release 09.13.2007
 
PRESS RELEASES
03.26.2008
 

Virtual Imaging Earns
ISO 13485:2003 Certification
DEERFIELD BEACH, FL – Virtual Imaging, Inc. received certification from Intertek that it is compliant with ISO 13485:2003, acknowledging that Virtual Imaging meets quality system requirements that are recognized across the world.
Created by the International Organization for Standardization, ISO 13485:2003 is an international standard, recognized throughout the world for establishing a quality management system specific to the medical device industry.  It is based on eight quality management principles: customer focus, leadership, involvement of people, process approach, system approach to management, continual improvement, fact based decision-making and mutually beneficial supplier relationships.  When fully adopted, these principles have been proven to enhance organizational performance.  ISO 13485:2003 puts an emphasis on documentation and requires management to identify potential problems and to implement appropriate practices in order to prevent those problems from further occurrence.
“ISO 13485:2003 Certification brings world class status to Virtual Imaging, and it provides confidence to our customers through our dedication to quality compliance,” says Ted Gersdorf, Virtual Imaging’s Corporate Compliance Manager.
By being ISO 13485:2003 certified, and registered by certification body Intertek, Virtual Imaging’s customers can be certain that the products they have purchased are developed and built within a controlled quality system with a clearer emphasis on documented policies and quality objectives as well as requiring top management’s support and commitment.  Through the certification process Virtual Imaging has established a quality management system that is oriented towards the design, development, production and installation of medical devices and related services.  
ISO is an international standard-setting body composed of representatives from various national standards organizations in 149 countries.  Founded on February 23, 1947, the organization sets world-wide industrial and commercial standards.  Though the ISO and the FDA have separate Quality System Regulations, the FDA participated in writing ISO 13485:2003, ensuring that the FDA’s requirements and ISO 13485:2003 are in agreement.
 
This document contains certain forward-looking statements about Virtual Imaging and its products. When used, the words "anticipates", "may", "can", "believes", "expects", "projects", "intends", "likely", similar expressions and any other statements that are not historical facts, in each case as they relate to Virtual Imaging, the management of the company or transaction are intended to identify those assertions as forward-looking statements. In making any such statements, the person making them believes that its expectations are based on reasonable assumptions. However, any such statement may be influenced by factors that could cause actual outcomes and results to be materially different from those projected or anticipated. These forward-looking statements are subject to numerous risks and uncertainties. There are various important factors that could cause actual results to differ materially from those in any such forward-looking statements, many of which are beyond the control of Virtual Imaging. The actual results or performance by Virtual Imaging could differ materially from those expressed in, or implied by, these forward-looking statements. Accordingly, no assurances can be given that any of the events anticipated by the forward-looking statements will transpire or occur, or if any of them do so, what impact they will have on the results of operations or financial condition of Virtual Imaging.
 

 

 

 

 
 
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