ISO 9001:2015
The certificate regulates the design, manufacture and assistance of electronic, electrochemical, electromedical equipment for magnetotherapy, design and production of electronic devices in the industrial field and electromedical equipment for stimulation and imaging.

Certificate IT325993 – AMEL SRL – ISO 9001 REV1 ENG

Original Cycle Start Date: October 17, 2017

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.