Fater life
Fater spa has obtained the UNI EN ISO 13485:2012 certification in relation to the plant of Pescara and the Headquarters for the development and production of high absorbency incontinence aids."
The UNI EN ISO 13485:2012 standard is harmonised to the Medical Devices Directive 93/42/EEC. The implementation of this standard provides organizations that apply it with the presumption of compliance with the mandatory requirements set out in the Medical Devices Directive. The standard also specifies the requirements for quality management systems that allow an organization to demonstrate its ability to provide medical devices and related services which meet customer requirements and regulatory requirements applicable to these devices.
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