Neusoft Positron Medical Systems, a joint venture between Positron and Neusoft Medical Systems, has received the CE Mark approval and ISO certification for its Attrius PET Systems.
This CE Mark is compulsory to market the products in the European Economic Area (EEA) and ensures that the products meet the requirements of the European conformity directives. It also indicates the products’ compliance with EU legislation. This mark conforms to all the legal requirements and facilitates the products to be marketed across the EEA.
The Attrius PET Systems can be marketed and distributed in the EU and other countries because of the CE mark approval. Currently, the contracting parties to the EEA comprise the EU and its 27 member states, which are United Kingdom, Spain, Sweden, Slovenia, Slovakia, Portugal, Poland, Romania, Netherlands, Latvia, Lithuania, Malta, Luxembourg, Italy, Denmark, Estonia, Ireland, Hungary ,Greece, France, Germany, Finland ,the Czech Republic, Austria, Belgium, Bulgaria and Cyprus and EEA/EFTA states like Iceland, Norway and Liechtenstein.
The ISO establishes a set of requirements that need to be fulfilled to meet customers’ needs through quality management. The certification is given when the needs are met consistently.
The ISO 9001:2008 certification requires an organization to meet customers’ needs constantly in terms of quality and consumer satisfaction, and fosters to improve customers’ satisfaction via a successful application of the system which includes methods for continual enhancement of the system and conforming to regulatory requirements.
Positron is a molecular imaging healthcare firm and promotes healthcare providers to diagnose disease and enhance patient health with cost effective medicines, through PET imaging systems, radiopharmaceuticals and radioisotopes solutions. It also provides solutions for Cardiac PET.
Source: www.positron.com