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, Sweden, and the United Kingdom), as well as, the three EEA/EFTA States, Iceland, Liechtenstein and Norway.
The International Organization for Standardization (ISO) sets the standards, relating to quality management systems and is designed to help organizations ensure that they meet the needs of customers and other stakeholders, while meeting statutory and regulatory requirements related to the product.
The ISO 9001:2008 certification specifies requirements for a quality management system where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
The ISO 13485:2003 certification specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems.
About Positron: Positron Corporation is a leading molecular imaging healthcare company vertically integrating all the segments of nuclear cardiology–providing an end-to-end solution for cardiac PET. Through proprietary PET imaging systems, radiopharmaceuticals and radioisotopes solutions, Positron enables healthcare providers to more accurately diagnose disease and improve patient outcomes, while practicing cost effective medicine. Positron’s unique products, market position and approach in securing the supply chain are substantial advantages, further accelerating the adoption of cardiac PET and growth of nuclear cardiology. Positron is redefining the industry. More information about Positron is available at www.positron.com.
Forward Looking Statements: Statements in this document contain certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. These statements are based on many assumptions and estimates and are not guarantees of future performance. These statements may involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Positron Corporation to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. Positron assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Our actual results may differ materially from the results anticipated in these forward-looking statements due to a variety of factors, including, without limitation those set forth as “Risk Factors” in our filings with the Securities and Exchange Commission.
SOURCE Positron Corporation