Certifications

EN ISO 13485:2016
The 93/42 / EEC European Directive regulates medical devices which include a very wide range of substances and products: as medical device is, in fact, intended any instrument, apparatus, plant, substance or other product, used alone or in combination, including software computer technician used for correct operation.

Certificate IT325992 – AMEL SRL – ISO 13485 REV1 ENG

The device created is intended by the manufacturer to be used in humans for the purpose of:

• diagnosis, prevention, control, therapy or attenuation of an illness   
• diagnosis, control, therapy, attenuation or compensation of a wound or handicap
• study, replacement or modification of the anatomy or of a physiological process intervention on conception

Devices of such an importance require particular attention to quality and safety: therefore, an ad hoc certification is required to demonstrate compliance with current regulations, as it is an exhaustive interpreter.