PET Systems Receive ISO Certification and CE Marking

Positron Corporation (Westmont, IL, USA), a leading molecular imaging healthcare company, announced that Neusoft Positron Medical Systems Co., Ltd., has received ISO certification (9001:2008 & 13485:2003) and the CE Marking 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 Positron Emission Tomography (PET) systems, based in Shenyang (China).

The CE Mark designation, a mandatory conformity marking for products placed on the market in the European Economic Area (EEA), will allow Positron Corporation to market, distribute, and service the Attrius to the EU and other countries that recognize the CE Marking. At present, the contracting parties to the EEA are the EU and its 27 member States, as well as, the 3 EEA/EFTA States.

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.

Neusoft Positron Medical Systems Co., Ltd., has stated that it has established and applies a quality management system and management system for medical devices in design and development, manufacture, distribution and service of PET Scanners.

Positron Corporation is a molecular imaging company vertically integrating all the segments of nuclear cardiology. 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.

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