Certifications

Striving for constant improvement has enabled Fisioline® to obtain certification for its Company Quality System in accordance with the UNI EN ISO 9001-2008 and UNI CEI EN 13485-2003 standards.

These certificates allow Fisioline® to effectively and safely operate the design, the production and the technical assistance of its products under a quality system that regulates the development. The devices therefore are built in conformity with the Directive and with the reference standards that regulate their construction. 

Fisioline® has always invested in scientific research reaching important goals as the FDA approval of its therapeutic laser devices. The FDA is the American governmental agency responsible for public health protection in US.

All electromedical equipment manufactured by Fisioline® comes with CE Medical certification, as required by the Directive 93/42/EEC, modified by the Directive 2007/47/EC on medical devices.

 

certificazione medicale       certificazione medicale