Amel Certification

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.

Amel ISO 9001

Starting certification date: August, 04, 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.

Amel ISO 13485

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.

Verified by ACCREDIA
Accredia is the single national accreditation body designated by the Italian government, in application of the Regolamento europeo 765/2008, to certify the competence, independence and impartiality of the certification, inspection and verification bodies, and of the testing and calibration laboratories. Accredia is a recognized association that operates non-profit, under the supervision of the Ministry of Economic Development.

Amel Accredia