Neusoft Positron Medical Systems Receives ISO Certification and CE Mark for their Attrius PET System
CHICAGO, Aug. 17, 2012 /PRNewswire/ -- Positron Corporation (OTCBB:POSC), a leading molecular imaging healthcare company, is pleased to announce that Neusoft Positron Medical Systems Co., Ltd., has received ISO certification (9001:2008 & 13485:2003) and CE Mark approval for their Attrius® PET Systems. Neusoft Positron Medical Systems is a joint venture between Neusoft Medical Systems Co., Ltd., and Positron Corporation for the development and manufacturing of PET systems and is based out of Shenyang, China.
Neusoft Positron Medical Systems Co., Ltd., has established and applies a quality management system and management system for medical devices in design and development, manufacture, distribution and service of Positron Emission Tomography (PET) Scanners.
A CE Mark is a mandatory conformity mark for products placed on the market in the European Economic Area (EEA). With the CE marking on a product, the manufacturer ensures that the product conforms to the essential requirements of the applicable European Conformity (EC) directives.
The CE marking is a key indicator of a product's compliance with the European Union (EU) legislation and enables the free movement of products within the European market. By affixing the CE marking on a product, a manufacturer is declaring, at their sole responsibility, conformity with all of the legal requirements to achieve CE marking and therefore ensuring validity for that product to be sold throughout the EEA.
The CE Mark designation will allow Positron Corporation to market, distribute and service the Attrius to the EU and other countries that recognize the CE Mark. At present, the contracting parties to the EEA are the EU and its 27 member States (Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,