01 Aug VASARIS ACQURES THE RIGHT
TO CE MARKING
SAFETY STANDARD FOR THE EXPORT OF PRODUCTS IN THE EUROPEAN UNION
BELGRADE, 1 August 2006. Visaris, the domestic manufacturer of modern digital X-ray machines, healthcare and laboratory information systems, and digital acquisition system, obtained the right to apply CE Marking. In addition to complying with ISO 9001, ISO 13485 and the EU Directive /93/42/EEC, the company has fulfilled all the safety standards for the export of its products to the European Union. Visaris’ products now meet the EU basic health, safety and environmental requirements.
Thereby, Visaris’ business is fully aligned with the adopted quality management systems according to the international quality standards: ISO9001 (General Quality Management Systems) and ISO13485 (Quality Management Systems for Medical Devices). The group of Visaris’ digital imaging systems for diagnostic radiology is in compliance with the EU Medical Device Directive 93/42/EEC and is eligible for the CE marking to safety standards. Visaris devices have also been registered with the Medicines and Medical Devices Agency of Serbia (ALIMS) and have a marketing authorization on the territory of the Republic of Serbia.